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PURPOSE To assess diagnostic performance of digital breast tomosynthesis (DBT) alone or combined with technologist-performed handheld screening ultrasound (US) in women with dense breasts. METHODS In an institutional review board–approved, Health Insurance Portability and Accountability Act–compliant multicenter protocol in western Pennsylvania, 6,179 women consented to three rounds of annual screening, interpreted by two radiologist observers, and had appropriate follow-up. Primary analysis was based on first observer results. RESULTS Mean participant age was 54.8 years (range, 40-75 years). Across 17,552 screens, there were 126 cancer events in 125 women (7.2/1,000; 95% CI, 5.9 to 8.4). In year 1, DBT-alone cancer yield was 5.0/1,000, and of DBT+US, 6.3/1,000, difference 1.3/1,000 (95% CI, 0.3 to 2.1; P = .005). In years 2 + 3, DBT cancer yield was 4.9/1,000, and of DBT+US, 5.9/1,000, difference 1.0/1,000 (95% CI, 0.4 to 1.5; P < .001). False-positive rate increased from 7.0% for DBT in year 1 to 11.5% for DBT+US and from 5.9% for DBT in year 2 + 3 to 9.7% for DBT+US ( P < .001 for both). Nine cancers were seen only by double reading DBT and one by double reading US. Ten interval cancers (0.6/1,000 [95% CI, 0.2 to 0.9]) were identified. Despite reduction in specificity, addition of US improved receiver operating characteristic curves, with area under receiver operating characteristic curve increasing from 0.83 for DBT alone to 0.92 for DBT+US in year 1 ( P = .01), with smaller improvements in subsequent years. Of 6,179 women, across all 3 years, 172/6,179 (2.8%) unique women had a false-positive biopsy because of DBT as did another 230/6,179 (3.7%) women because of US ( P < .001). CONCLUSION Overall added cancer detection rate of US screening after DBT was modest at 19/17,552 (1.1/1,000; CI, 0.5- to 1.6) screens but potentially overcomes substantial increases in false-positive recalls and benign biopsies.

ObjectiveEvaluate lesion visibility and radiologist confidence during contrast-enhanced mammography (CEM)-guided biopsy.MethodsWomen with BI-RADS ≥4A enhancing breast lesions were prospectively recruited for 9-g vacuum-assisted CEM-guided biopsy. Breast density, background parenchymal enhancement (BPE), lesion characteristics (enhancement and conspicuity), radiologist confidence (scale 1–5), and acquisition times were collected. Signal intensities in specimens were analyzed. Patient surveys were collected.ResultsA cohort of 28 women aged 40–81 years (average 57) had 28 enhancing lesions (7/28, 25% malignant). Breast tissue was scattered (10/28, 36%) or heterogeneously dense (18/28, 64%) with minimal (12/28, 43%), mild (7/28, 25%), or moderate (9/28, 32%) BPE on CEM. Twelve non-mass enhancements, 11 masses, 3 architectural distortions, and 2 calcification groups demonstrated weak (12/28, 43%), moderate (14/28, 50%), or strong (2/28, 7%) enhancement. Specimen radiography demonstrated lesion enhancement in 27/28 (96%). Radiologists reported complete lesion removal on specimen radiography in 8/28 (29%). Average time from contrast injection to specimen radiography was 18 minutes (SD = 5) and, to post-procedure mammogram (PPM), 34 minutes (SD = 10). Contrast-enhanced mammography PPM was performed in 27/28 cases; 13/19 (68%) of incompletely removed lesions on specimen radiography showed residual enhancement; 6/19 (32%) did not. Across all time points, average confidence was 2.2 (SD = 1.2). Signal intensities of enhancing lesions were similar to iodine. Patients had an overall positive assessment.ConclusionLesion enhancement persisted through PPM and was visible on low energy specimen radiography, with an average “confident” score. Contrast-enhanced mammography-guided breast biopsy is easily implemented clinically. Its availability will encourage adoption of CEM.

Objective To assess prospectively the interpretative performance of automated breast ultrasound (ABUS) as a supplemental screening after digital breast tomosynthesis (DBT) or as a standalone screening of women with dense breast tissue. Methods Under an IRB-approved protocol (written consent required), women with dense breasts prospectively underwent concurrent baseline DBT and ABUS screening. Examinations were independently evaluated, in opposite order, by two of seven Mammography Quality Standards Act–qualified radiologists, with the primary radiologist arbitrating disagreements and making clinical management recommendations. We report results for 1111 screening examinations (598 first year and 513 second year) for which all diagnostic workups are complete. Imaging was also retrospectively reviewed for all cancers. Statistical assessments used a 0.05 significance level and accounted for correlation between participants’ examinations. Results Of 1111 women screened, primary radiologists initially “recalled” based on DBT alone (6.6%, 73/1111, CI: 5.2%–8.2%), of which 20 were biopsied, yielding 6/8 total cancers. Automated breast ultrasound increased recalls overall to 14.4% (160/1111, CI: 12.4%–16.6%), with 27 total biopsies, yielding 1 additional cancer. Double reading of DBT alone increased the recall rate to 10.7% (119/1111), with 21 biopsies, with no improvement in cancer detection. Double reading ABUS increased the recall rate to 15.2% (169/1111, CI: 13.2%–17.5%) of women, of whom 22 were biopsied, yielding the detection of 7 cancers, including one seen only on double reading ABUS. Inter-radiologist agreement was similar for recall recommendations from DBT (κ = 0.24, CI: 0.14–0.34) and ABUS (κ = 0.23, CI: 0.15–0.32). Integrated assessments from both readers resulted in a recall rate of 15.1% (168/1111, CI: 13.1%–17.4%). Conclusion Supplemental or standalone ABUS screening detected cancers not seen on DBT, but substantially increased noncancer recall rates.

Background Staging newly diagnosed breast cancer by using dynamic contrast material-enhanced MRI is limited by access, high cost, and false-positive findings. The utility of contrast-enhanced mammography (CEM) and 99mTc sestamibi-based molecular breast imaging (MBI) in this setting is largely unknown. Purpose To compare extent-of-disease assessments by using MRI, CEM, and MBI versus pathology in women with breast cancer. Materials and Methods In this HIPAA-compliant prospective study, women with biopsy-proven breast cancer underwent MRI, CEM, and MBI between October 2014 and April 2018. Eight radiologists independently interpreted each examination result prospectively and were blinded to interpretations of findings with the other modalities. Visibility of index malignancies, lesion size, and additional suspicious lesions (malignant or benign) were compared during pathology review. Accuracy of index lesion sizing and detection of additional lesions in women without neoadjuvant chemotherapy were compared. Results A total of 102 women were enrolled and 99 completed the study protocol (mean age, 51 years ± 11 [standard deviation]; range, 32-77 years). Lumpectomy or mastectomy was performed in 71 women (79 index malignancies) without neoadjuvant chemotherapy and in 28 women (31 index malignancies) with neoadjuvant chemotherapy. Of the 110 index malignancies, MRI, CEM, and MBI depicted 102 (93%; 95% confidence interval [CI]: 86%, 97%), 100 (91%; 95% CI: 84%, 96%), and 101 (92%; 95% CI: 85%, 96%) malignancies, respectively. In patients without neoadjuvant chemotherapy, pathologic size of index malignancies was overestimated with all modalities (P = .02). MRI led to overestimation of 24% (17 of 72) of malignancies by more than 1.5 cm compared with 11% (eight of 70) with CEM and 15% (11 of 72) with MBI. MRI depicted more (P = .007) nonindex lesions, with sensitivity similar to that of CEM or MBI, resulting in lower positive predictive value of additional biopsies (13 of 46 [28%; 95% CI: 17%, 44%] for MRI; 14 of 27 [52%; 95% CI: 32%, 71%] for CEM; and 11 of 25 [44%; 95% CI: 24%, 65%] for MBI (overall P = .01). Conclusion Contrast-enhanced mammography, molecular breast imaging, and MRI showed similar detection of all malignancies. MRI depicted more nonindex suspicious benign lesions than did contrast-enhanced mammography or molecular breast imaging, leading to lower positive predictive value of additional biopsies. All three modalities led to overestimation of index tumor size, particularly MRI. © RSNA, 2019 Online supplemental material is available for this article.

ORIGINAL RESEARCH ABSTRACT PURPOSE The purpose of this study was to investigate if human-extracted MRI tumor phenotypes of breast cancer could predict receptor status and tumor molecular subtype using MRIs from The Cancer Genome Atlas project. MATERIALS AND METHODS Our retrospective interpretation study utilized the analysis of HIPAA-compliant breast MRI data from The Cancer Imaging Archive. One hundred and seven preoperative breast MRIs of biopsy proven invasive breast cancers were analyzed by 3 fellowship-trained breast-imaging radiologists. Each study was scored according to the Breast Imaging Reporting and Data System lexicon for mass and nonmass features. The Spearman rank correlation was used for association analysis of continuous variables; the Kruskal-Wallis test was used for associating continuous outcomes with categorical variables. The Fisher-exact test was used to assess correlations between categorical image-derived features and receptor status. Prediction of estrogen receptor (ER), progesterone receptor, human epidermal growth factor receptor, and molecular subtype were performed using random forest classifiers. RESULTS ER+ tumors were associated with the absence of rim enhancement (P = 0.019, odds ratio [OR] 5.5), heterogeneous internal enhancement (P = 0.02, OR 6.5), peritumoral edema (P = 0.0001, OR 10.0), and axillary adenopathy (P = 0.04, OR 4.4). ER+ tumors were smaller than ER− tumors (23.7 mm vs 29.2 mm, P = 0.02, OR 8.2). All of these variables except the lack of axillary adenopathy were also associated with progesterone receptor+ status. Luminal A tumors (n = 57) were smaller compared to nonLuminal A (21.8 mm vs 27.5 mm, P = 0.035, OR 7.3) and lacked peritumoral edema ( P = 0.001, OR 6.8). Basal like tumors were associated with heterogeneous internal enhancement (P = 0.05, OR 10.1), rim enhancement (P = 0.05, OR6.9), and perituomral edema (P = 0.0001, OR 13.8). CONCLUSIONS Human extracted MRI tumor phenotypes may be able to differentiate those tumors with a more favorable clinical prognosis from their more aggressive counterparts.

To preliminarily asses if Contrast Enhanced Digital Mammography (CEDM) can accurately reduce biopsy rates for soft tissue BI-RADS 4A or 4B lesions.Eight radiologists retrospectively and independently reviewed 60 lesions in 54 consenting patients who underwent CEDM under Health Insurance Portability and Accountability Act compliant institutional review board-approved protocols. Readers provided Breast Imaging ReportingData System ratings sequentially for digital mammography/digital breast tomosynthesis (DM/DBT), then with ultrasound, then with CEDM for each lesion. Area under the curve (AUC), true positive rates and false positive rates, positive predictive values and negative predictive values were calculated. Statistical analysis accounting for correlation between lesion-examinations and between-reader variability was performed using OR/DBM (for SAS v.3.0), generalized linear mixed model for binary data (proc glimmix, SAS v.9.4, SAS Institute, Cary North Carolina), and bootstrap.The cohort included 49 benign, two high-risk and nine cancerous lesions in 54 women aged 34-74 (average 50) years. Reader-averaged AUC for CEDM was significantly higher than DM/DBT alone (0.85 versus 0.66, p0.001) or with US (0.85 versus 0.75, p = 0.001). CEDM increased true positive rates from 0.74 under DB/DBT, and 0.89 with US, to 0.90 with CEDM, (p = 0.019 DM/DBT versus CEDM, p = 0.78 DM/DBT + US versus CEDM) and decreased false positive rates from 0.47 using DM/DBT and 0.61 with US to 0.39 with CEDM (p = 0.017 DM/DBT versus CEDM, p = 0.001 DM/DBT+ US versus CEDM). For an expected cancer rate of 10%, CEDM positive predictive values was 20.5% (95% CI: 16%-27%) and negative predictive values 98.3% (95% CI: 96%-100%).Addition of CEDM for evaluation of low-moderate suspicion soft tissue breast lesions can substantially reduce biopsy of benign lesions without compromising cancer detection.

Breast imaging is an essential component of breast cancer diagnosis and guides surgery and treatment options. Imaging techniques such as mammography, ultrasound (US), and magnetic resonance imaging (MRI) enable the detection of breast cancer at earlier stages. Mammography remains the standard screening examination; however, additional imaging studies are useful in evaluating the breast. US is utilized primarily in the diagnostic setting to characterize mammographic or palpable findings and assess axillary lymph nodes. Supplemental screening US may also be useful in patients with intermediate risk for developing breast cancer and dense breasts to increase cancer detection. In addition to mammography, high-risk patients may also have annual MRI or screening US if they are unable to undergo MRI. MRI is also performed to evaluate the extent of disease, the response to neoadjuvant chemotherapy, and silicone implant integrity. In addition, these imaging modalities are also used to guide percutaneous biopsy, enabling minimally invasive tissue diagnosis. There is insufficient evidence to support the screening use of investigational imaging modalities, such as nuclear medicine breast imaging, and positron emission mammography. However, these topics are briefly discussed for completeness.

Rationale and Objectives Assess results of a prospective, single-site clinical study evaluating digital breast tomosynthesis (DBT) during baseline screening mammography. Materials and Methods Under an institutional review board–approved Health Insurance Portability and Accountability Act (HIPAA)-compliant protocol, consenting women between ages 34 and 56 years scheduled for their initial and/or baseline screening mammogram underwent both full field digital mammography (FFDM) and DBT. The FFDM and the FFDM plus DBT images were interpreted independently in a reader by mode balanced approach by two of 14 participating radiologists. A woman was recalled for a diagnostic work-up if either radiologist recommended a recall. We report overall recall rates and related diagnostic outcome from the 1080 participants. Proportion of recommended recalls (Breast Imaging Reporting and Data System 0) were compared using a generalized linear mixed model (SAS 9.3) with a significance level of P = .0294. Results The fraction of women without breast cancer recommended for recall using FFDM alone and FFDM plus DBT were 412 of 1074 (38.4%) and 274 of 1074 (25.5%), respectively ( P P Conclusions The use of FFDM plus DBT resulted in a significant decrease in recall rates during baseline screening mammography with no reduction in sensitivity.

Interpretations of breast ultrasound screening examinations result in high recall rates and large inter-radiologist variability, frequently leading to “conservative” recommendations. Double reading of all breast ultrasound screening examinations is cost prohibitive, but double reading of only “initially recalled” cases may prove efficacious. We assessed changes in recommendations, if any, by providing a consensus second opinion in a limited subset of examinations initially recommended for recall. We performed a retrospective reader study with 197 ultrasound examinations (97 not recalled and 100 recalled clinically). First, we generated a consensus “second opinion” consisting of the majority vote of three independent readings of each case by experienced ultrasound interpreters. During the reader study that followed, if the reader recommended a “recall” and the “consensus second opinion” did not, a message to that effect was displayed and the reader was asked to re-review the exam and re-assess if, knowing the second opinion, a re-rating of the case was warranted. We compared performance levels pre- and post- the second opinion. The second opinion resulted in “no recall” recommendations of 141 cases in the entire set, including four cancer cases missed by all three readers. On average, radiologists received “warning” messages in 30 cases (range 15-50), or in ~15% of cases. Rating changes (downgrades to no recall) occurred in 36 of these cases. These changes resulted in a possible recall rate reduction of 28% in prompted cases or 14% overall recall reduction, while increasing the false negative rate by only one case missed by 2 readers (~1%).

The purpose of this study was to compare outcomes of radioactive seed localization (RSL) versus wire localization using surgical margin size, reexcision and reoperation rates, specimen size, radiology resource utilization, and cosmesis as measures.Patients who underwent RSL before segmental mastectomy from April 1, 2011, to March 1, 2012, for biopsy-proven cancer were selected. Each was matched using tumor size, type, and surgeon to a wire localization control case, resulting in 232 cases. Width of the closest surgical margin, reexcision rate, and reoperation rate were compared as were the ratios of tumor volume to initial surgical specimen volume and tumor volume to all surgically excised volume (including reexcisions and reoperations). Cosmetic outcome was analyzed by comparison of Harvard scores and specimen volume with breast volume. Radiology resource utilization was compared before and after RSL implementation.No significant differences between methods were found in closest surgical margin (RSL mean, 0.45 cm; wire localization mean, 0.45 cm; p=0.972), reexcision rate (RSL mean, 21.1%; wire localization mean, 26.3%; p=0.360), reoperation rate (RSL, 11.4%; wire localization, 12.7%; p=0.841), ratio of the tumor volume to initial surgical specimen volume (RSL mean, 0.027; wire localization mean, 0.028; p=0.886), ratio of the tumor volume to total volume resected (RSL mean, 0.024; wire localization mean, 0.024; p=0.997), or in clinical or computed cosmesis scores (clinical p=0.5; calculated p=0.060). There was a 34% increase in scheduled biopsy slot utilization, 50% savings in time spent scheduling, and a 4.1-day average decrease in biopsy wait time after RSL institution.RSL is an acceptable alternative to wire localization and offers significant improvements in workflow.

Background In this study, we sought to investigate if computer-extracted magnetic resonance imaging (MRI) phenotypes of breast cancer could replicate human-extracted size and Breast Imaging-Reporting and Data System (BI-RADS) imaging phenotypes using MRI data from The Cancer Genome Atlas (TCGA) project of the National Cancer Institute. Methods Our retrospective interpretation study involved analysis of Health Insurance Portability and Accountability Act-compliant breast MRI data from The Cancer Imaging Archive, an open-source database from the TCGA project. This study was exempt from institutional review board approval at Memorial Sloan Kettering Cancer Center and the need for informed consent was waived. Ninety-one pre-operative breast MRIs with verified invasive breast cancers were analysed. Three fellowship-trained breast radiologists evaluated the index cancer in each case according to size and the BI-RADS lexicon for shape, margin, and enhancement (human-extracted image phenotypes [HEIP]). Human inter-observer agreement was analysed by the intra-class correlation coefficient (ICC) for size and Krippendorff’s α for other measurements. Quantitative MRI radiomics of computerised three-dimensional segmentations of each cancer generated computer-extracted image phenotypes (CEIP). Spearman’s rank correlation coefficients were used to compare HEIP and CEIP. Results Inter-observer agreement for HEIP varied, with the highest agreement seen for size (ICC 0.679) and shape (ICC 0.527). The computer-extracted maximum linear size replicated the human measurement with p

Background Imaging features derived from MRI scans can be used for not only breast cancer detection and measuring disease extent, but can also determine gene expression and patient outcomes. The relationships between imaging features, gene/protein expression, and response to therapy hold potential to guide personalized medicine. We aim to characterize the relationship between radiologist-annotated tumor phenotypic features (based on MRI) and the underlying biological processes (based on proteomic profiling) in the tumor. Methods Multiple-response regression of the image-derived, radiologist-scored features with reverse-phase protein array expression levels generated association coefficients for each combination of image-feature and protein in the RPPA dataset. Significantly-associated proteins for features were analyzed with Ingenuity Pathway Analysis software. Hierarchical clustering of the results of the pathway analysis determined which features were most strongly correlated with pathway activity and cellular functions. Results Each of the twenty-nine imaging features was found to have a set of significantly correlated molecules, associated biological functions, and pathways. Conclusions We interrogated the pathway alterations represented by the protein expression associated with each imaging feature. Our study demonstrates the relationships between biological processes (via proteomic measurements) and MRI features within breast tumors.

RATIONALE AND OBJECTIVES To assess the interaction between the availability of prior examinations and digital breast tomosynthesis (DBT) in decisions to recall a woman during interpretation of mammograms. MATERIALS AND METHODS Eight radiologists independently interpreted twice 36 mammography examinations, each of which had current and prior full-field digital mammography images (FFDM) and DBT under a Health Insurance Portability and Accountability Act-compliant, institutional review board-approved protocol (written consent waived). During the first reading, three sequential ratings were provided using FFDM only, followed by FFDM + DBT, and then followed by FFDM + DBT + priors. The second reading included FFDM only, then FFDM + priors, and then FFDM + priors + DBT. Twenty-two benign cases clinically recalled, 12 negative/benign examinations (not recalled), and two verified cancer cases were included. Recall recommendations and interaction between the effect of priors and DBT on decisions were assessed (P = .05 significance level) using generalized linear model (PROC GLIMMIX, SAS, version 9.3; SAS Institute, Cary, NC) accounting for case and reader variability. RESULTS Average recall rates in noncancer cases were significantly reduced (51%; P < .001) with the addition of DBT and with addition of priors (23%; P = .01). In absolute terms, the addition of DBT to FFDM reduced the recall rates from 0.67 to 0.42 and from 0.54 to 0.27 when DBT was available before and after priors, respectively. Recall reductions were from 0.64 to 0.54 and from 0.42 to 0.33 when priors were available before and after DBT, respectively. Regardless of the sequence in presentation, there were no statistically significant interactions between the effect of availability of DBT and priors (P = .80). CONCLUSIONS Availability of both priors and DBT are independent primary factors in reducing recall recommendations during mammographic interpretations.

The purpose of this study was to determine the frequency of carcinoma identified with secondary presurgical imaging-guided percutaneous biopsy for patients with high-risk pathologic findings at primary percutaneous biopsy.A retrospective computerized search of our breast imaging database from January 1, 2005, to October 1, 2010, was conducted to identify the cases of patients with high-risk pathologic findings at primary biopsy who underwent at least one secondary biopsy within 9 months and underwent surgical excision. Lesion type, location, biopsy guidance, device, number of samples, and histopathologic findings were recorded. The pathologic findings at surgical excision were compared with the percutaneous biopsy results.One hundred twenty-three patients underwent 158 secondary biopsies. On average, 1.3 additional biopsies were performed per patient. Among the 158 secondary biopsies, 105 (66.4%) had benign, 48 (30.4%) had high-risk, and five (3.2%) had malignant histopathologic findings. No malignant tumors were identified at secondary percutaneous biopsies in cases in which the same lesion type was biopsied in the same quadrant. Use of secondary percutaneous biopsy led to detection of nine malignant tumors in 7.3% of patients-with percutaneous biopsy in four (3.2%) patients and at surgical excision in five (4.1%) patients.After initial imaging-guided percutaneous biopsy reveals high-risk pathologic findings, identification of additional high-risk lesions at secondary percutaneous biopsy is common, and detection of malignancy is relatively infrequent. However, because the secondarily identified high-risk lesions are sometimes upstaged to cancer at surgical excision, additional imaging-directed biopsy has potential benefit for patients with known highrisk lesions and multiple synchronous findings.

Purpose To investigate relationships between computer-extracted breast magnetic resonance (MR) imaging phenotypes with multigene assays of MammaPrint, Oncotype DX, and PAM50 to assess the role of radiomics in evaluating the risk of breast cancer recurrence. Materials and Methods Analysis was conducted on an institutional review board-approved retrospective data set of 84 deidentified, multi-institutional breast MR examinations from the National Cancer Institute Cancer Imaging Archive, along with clinical, histopathologic, and genomic data from The Cancer Genome Atlas. The data set of biopsy-proven invasive breast cancers included 74 (88%) ductal, eight (10%) lobular, and two (2%) mixed cancers. Of these, 73 (87%) were estrogen receptor positive, 67 (80%) were progesterone receptor positive, and 19 (23%) were human epidermal growth factor receptor 2 positive. For each case, computerized radiomics of the MR images yielded computer-extracted tumor phenotypes of size, shape, margin morphology, enhancement texture, and kinetic assessment. Regression and receiver operating characteristic analysis were conducted to assess the predictive ability of the MR radiomics features relative to the multigene assay classifications. Results Multiple linear regression analyses demonstrated significant associations (R2 = 0.25-0.32, r = 0.5-0.56, P < .0001) between radiomics signatures and multigene assay recurrence scores. Important radiomics features included tumor size and enhancement texture, which indicated tumor heterogeneity. Use of radiomics in the task of distinguishing between good and poor prognosis yielded area under the receiver operating characteristic curve values of 0.88 (standard error, 0.05), 0.76 (standard error, 0.06), 0.68 (standard error, 0.08), and 0.55 (standard error, 0.09) for MammaPrint, Oncotype DX, PAM50 risk of relapse based on subtype, and PAM50 risk of relapse based on subtype and proliferation, respectively, with all but the latter showing statistical difference from chance. Conclusion Quantitative breast MR imaging radiomics shows promise for image-based phenotyping in assessing the risk of breast cancer recurrence. © RSNA, 2016 Online supplemental material is available for this article.

Performance changes in a binary environment when using additional information is affected only when changes in recommendations are made due to the additional information in question. In a recent study, we have shown that, contrary to general expectation, introducing prior examinations improved recall rates, but not sensitivity. In this study, we assessed cancer detection differences when prior examinations and/or digital breast tomosynthesis (DBT) were made available to the radiologist. We identified a subset of 21 cancer cases with differences in the number of radiologists who recalled these cases after reviewing either a prior examination or DBT. For the cases with differences in recommendations after viewing either priors or DBT, separately, we evaluated the total number of readers that changed their recommendations, regardless of the specific radiologist in question. Confidence intervals for the number of readers and a test for the hypothesis of no difference was performed using the non-parameteric bootstrap approach addressing both case and reader-related sources of variability by resampling cases and readers. With the addition of priors, there were 14 cancer cases (out of 15) where the number of “recalling radiologists” decreased. With the addition of DBT, the number of “recalling radiologists” decreased in only five cases (out of 15) while increasing in the remaining 9 cases. Unlike most new approaches to breast imaging DBT seems to improve both recall rates and cancer detection rates. Changes in recommendations were noted by all radiologists for all cancers by type, size, and breast density.

Rationale and Objectives The aim of this study was to retrospectively compare the interpretive performance of synthetically reconstructed two-dimensional images in combination with digital breast tomosynthesis (DBT) versus full-field digital mammography (FFDM) plus DBT. Materials and Methods Ten radiologists trained in reading tomosynthesis examinations interpreted retrospectively, under two modes, 114 mammograms. One mode included the directly acquired full-field digital mammograms combined with DBT, and the other included synthetically reconstructed projection images combined with DBT. The reconstructed images do not require additional radiation exposure. The two modes were compared with respect to sensitivity, namely, recommendation to recall a breast with either a pathology-proven cancer ( n = 48) or a high-risk lesion ( n = 6), and specificity, namely, no recommendation to recall a breast not depicting an abnormality ( n = 144) or depicting only benign abnormalities ( n = 30). Results The average sensitivity for FFDM with DBT was 0.826, compared to 0.772 for synthetic FFDM with DBT (difference, 0.054; P = .017 and P = .053 for fixed and random reader effects, respectively). The proportions of breasts with no or benign abnormalities recommended to be recalled were virtually the same: 0.298 and 0.297 for the two modalities, respectively (95% confidence intervals for the difference, −0.028 to 0.036 and −0.070 to 0.066 for fixed and random reader effects, respectively). Sixteen additional clusters of microcalcifications (“positive” breasts) were missed by all readers combined when interpreting the mode with synthesized images versus FFDM. Conclusions Lower sensitivity with comparable specificity was observed with the tested version of synthetically generated images compared to FFDM, both combined with DBT. Improved synthesized images with experimentally verified acceptable diagnostic quality will be needed to eliminate double exposure during DBT-based screening.

The purpose of this article is to compare the ability of digital breast tomosynthesis and full field digital mammography (FFDM) to detect and characterize calcifications.One hundred paired examinations were performed utilizing FFDM and digital breast tomosynthesis. Twenty biopsy-proven cancers, 40 biopsy-proven benign calcifications, and 40 randomly selected negative screening studies were retrospectively reviewed by five radiologists in a crossed multireader multimodal observer performance study. Data collected included the presence of calcifications and forced BI-RADS scores. Receiver operator curve analysis using BI-RADS was performed.Overall calcification detection sensitivity was higher for FFDM (84% [95% CI, 79-88%]) than for digital breast tomosynthesis (75% [95% CI, 70-80%]). [corrected] In the cancer cohort, 75 (76%) of 99 interpretations identified calcification in both modes. Of those, a BI-RADS score less than or equal to 2 was rendered in three (4%) and nine (12%) cases with FFDM and digital breast tomosynthesis, respectively. In the benign cohort, 123 (62%) of 200 interpretations identified calcifications in both modes. Of those, a BI-RADS score greater than or equal to 3 was assigned in 105 (85%) and 93 (76%) cases with FFDM and digital breast tomosynthesis, respectively. There was no significant difference in the nonparametric computed area under the receiver operating characteristic curves (AUC) using the BI-RADS scores (FFDM, AUC = 0.76 and SD = 0.03; digital breast tomosynthesis, AUC = 0.72 and SD = 0.04 [p = 0.1277]).In this small data set, FFDM appears to be slightly more sensitive than digital breast tomosynthesis for the detection of calcification. However, diagnostic performance as measured by area under the curve using BI-RADS was not significantly different. With improvements in processing algorithms and display, digital breast tomosynthesis could potentially be improved for this purpose.

Rationale and Objectives Computerized determination of optimal search areas on mammograms for matching breast mass regions depicted on two ipsilateral views remains a challenge for developing multiview-based computer-aided detection (CAD) schemes. The purpose of this study was to compare three methods aimed at matching CAD-cued mass regions depicted on two views and the associated impact on CAD performance. Materials and Methods The three search methods used (1) an annular (fan-shaped) band, (2) a straight strip perpendicular to the estimated centerline, and (3) a mixed search area bound on the chest wall side by a straight line and an annular arc on the nipple side, respectively. An image database of 200 examinations with positive results depicting the masses on two views and 200 examinations with negative results was used for testing. Two performance assessment experiments were conducted. The first investigated the maximum matching sensitivity as a function of the search area size, and the second assessed the change in CAD performance using these three search methods. Results To include all 200 paired mass regions within the search areas, maximum widths were 28 and 68 mm for the use of the straight strip and the annular band search methods, respectively. When applying a single-image-based CAD scheme to this image database, 172 masses (86% sensitivity) and 523 false-positive (FP) regions (0.33 per image) were detected and cued. Among the positive findings, 92 were cued by the CAD system on both views, and 80 were cued on only one view. In an attempt to match as many of the 172 CAD-cued masses (true-positive [TP] regions) on two views by incrementally reducing the CAD threshold inside the different search areas, the CAD scheme generated 158 TP-TP paired matches with 14 TP-FP paired matches, 142 TP-TP paired matches with 30 TP-FP paired matches, and 146 TP-TP paired matches with 26 TP-FP paired matches, using the methods involving the straight strip, the annular band, and the mixed search areas, respectively. Using the straight strip search method, the CAD also eliminated 25% of FP regions initially cued by the single-image-based CAD scheme and generated the lowest case-based FP detection rate, namely, 15% less than that generated by the annular band method. Conclusions This study showed that among these three search methods, the straight strip method required a smaller search area and achieved the highest level of CAD performance.

Rationale and Objectives To investigate consistency of the orders of performance levels when interpreting mammograms under three different reading paradigms. Materials and Methods We performed a retrospective observer study in which nine experienced radiologists rated an enriched set of mammography examinations that they personally had read in the clinic (“individualized”) mixed with a set that none of them had read in the clinic (“common set”). Examinations were interpreted under three different reading paradigms: binary using screening Breast Imaging Reporting and Data System (BI-RADS), receiver-operating characteristic (ROC), and free-response ROC (FROC). The performance in discriminating between cancer and noncancer findings under each of the paradigms was summarized using Youden's index/2+0.5 (Binary), nonparameteric area under the ROC curve (AUC), and an overall FROC index (JAFROC-2). Pearson correlation coefficients were then computed to assess consistency in the ordering of observers' performance levels. Statistical significance of the computed correlation coefficients was assessed using bootstrap confidence intervals obtained by resampling sets of examination-specific observations. Results All but one of the computed pair-wise correlation coefficients were larger than 0.66 and were significantly different from zero. The correlation between the overall performance measures under the Binary and ROC paradigms was the lowest (0.43) and was not significantly different from zero (95% confidence interval −0.078 to 0.733). Conclusion The use of different evaluation paradigms in the laboratory tends to lead to consistent ordering of the overall performance levels of observers. However, one should recognize that conceptually similar performance indexes resulting from different paradigms often measure different performance characteristics and thus disagreements are not only possible but frequently quite natural.

The authors investigated radiologists, performances during retrospective interpretation of screening mammograms when using a binary decision whether to recall a woman for additional procedures or not and compared it with their receiver operating characteristic (ROC) type performance curves using a semi-continuous rating scale. Under an Institutional Review Board approved protocol nine experienced radiologists independently rated an enriched set of 155 examinations that they had not personally read in the clinic, mixed with other enriched sets of examinations that they had individually read in the clinic, using both a screening BI-RADS rating scale (recall/not recall) and a semi-continuous ROC type rating scale (0 to 100). The vertical distance, namely the difference in sensitivity levels at the same specificity levels, between the empirical ROC curve and the binary operating point were computed for each reader. The vertical distance averaged over all readers was used to assess the proximity of the performance levels under the binary and ROC-type rating scale. There does not appear to be any systematic tendency of the readers towards a better performance when using either of the two rating approaches, namely four readers performed better using the semi-continuous rating scale, four readers performed better with the binary scale, and one reader had the point exactly on the empirical ROC curve. Only one of the nine readers had a binary "operating point" that was statistically distant from the same reader's empirical ROC curve. Reader-specific differences ranged from -0.046 to 0.128 with an average width of the corresponding 95% confidence intervals of 0.2 and p-values ranging for individual readers from 0.050 to 0.966. On average, radiologists performed similarly when using the two rating scales in that the average distance between the run in individual reader's binary operating point and their ROC curve was close to zero. The 95% confidence interval for the fixed-reader average (0.016) was (-0.0206, 0.0631) (two-sided p-value 0.35). In conclusion the authors found that in retrospective observer performance studies the use of a binary response or a semi-continuous rating scale led to consistent results in terms of performance as measured by sensitivity-specificity operating points.

The clinical utility of interactive computer-aided diagnosis (ICAD) systems depends on clinical relevance and visual similarity between the queried breast lesions and the ICAD-selected reference regions. The objective of this study is to develop and test a new ICAD scheme that aims improve visual similarity of ICAD-selected reference regions.A large and diverse reference library involving 3,000 regions of interests was established. For each queried breast mass lesion by the observer, the ICAD scheme segments the lesion, classifies its boundary spiculation level, and computes 14 image features representing the segmented lesion and its surrounding tissue background. A conditioned k-nearest neighbor algorithm is applied to select a set of the 25 most "similar" lesions from the reference library. After computing the mutual information between the queried lesion and each of these initially selected 25 lesions, the scheme displays the six reference lesions with the highest mutual information scores. To evaluate the automated selection process of the six "visually similar" lesions to the queried lesion, we conducted a two-alternative forced-choice observer preference study using 85 queried mass lesions. Two sets of reference lesions selected by one new automated ICAD scheme and the other previously reported scheme using a subjective rating method were randomly displayed on the left and right side of the queried lesion. Nine observers were asked to decide for each of the 85 queried lesions which one of the two reference sets was "more visually similar" to the queried lesion.In classification of mass boundary spiculation levels, the overall agreement rate between the automated scheme and an observer is 58.8% (Kappa = 0.31). In observer preference study, the nine observers preferred on average the reference lesion sets selected by the automated scheme as being more visually similar than the set selected by the subjective rating approach in 53.2% of the queried lesions. The results were not significantly different for the two methods (P = .128).This study suggests that using the new automated ICAD scheme, the interobserver variability related issues can thus be avoided. Furthermore, the new scheme maintains the similar performance level as the previous scheme using the subjective rating method that can select reference sets that are significantly more visually similar (P.05) than when using traditional ICAD schemes in which the mass boundary spiculation levels are not accurately detected and quantified.

Assess results of a prospective, single-site clinical study evaluating digital breast tomosynthesis (DBT) during baseline screening mammography.Under an institutional review board-approved Health Insurance Portability and Accountability Act (HIPAA)-compliant protocol, consenting women between ages 34 and 56 years scheduled for their initial and/or baseline screening mammogram underwent both full field digital mammography (FFDM) and DBT. The FFDM and the FFDM plus DBT images were interpreted independently in a reader by mode balanced approach by two of 14 participating radiologists. A woman was recalled for a diagnostic work-up if either radiologist recommended a recall. We report overall recall rates and related diagnostic outcome from the 1080 participants. Proportion of recommended recalls (Breast Imaging Reporting and Data System 0) were compared using a generalized linear mixed model (SAS 9.3) with a significance level of P = .0294.The fraction of women without breast cancer recommended for recall using FFDM alone and FFDM plus DBT were 412 of 1074 (38.4%) and 274 of 1074 (25.5%), respectively (P.001). Large inter-reader variability in terms of recall reduction was observed among the 14 readers; however, 11 of 14 readers recalled fewer women using FFDM plus DBT (5 with P.015). Six cancers (four ductal carcinomas in situ [DCIS] and two invasive ductal carcinomas [IDC]) were detected. One IDC was detected only on DBT and one DCIS cancer was detected only on FFDM, whereas the remaining cancers were detected on both modalities.The use of FFDM plus DBT resulted in a significant decrease in recall rates during baseline screening mammography with no reduction in sensitivity.

To prospectively survey women undergoing screening mammography to assess their attitudes toward and preference for the level of recall rates given the possibility that an increase in recall rates may result in earlier detection of cancer.This HIPAA-compliant survey was performed with an institutional review board-approved protocol. Women who arrived for their routine screening mammographic examination from November 2004 to March 2005 were informed before they consented to participate. The distribution of responses for each survey question was summarized, and proportions for the entire group and different subgroups were computed. The z score statistic was used to assess significant differences between subgroups.Fifteen hundred seventy anonymized questionnaires were collected; 1171 (75%) were from women between 40 and 59 years of age. Of 1528 respondents, 1486 (97%) believed that a false-positive result would not deter them from continuing with regular screening, and most would have been willing to be recalled more often for either a noninvasive (86% [1308 of 1519 respondents]) or an invasive (82% [1248 of 1515 respondents]) procedure if it might increase the chance of detecting a cancer (if present) earlier. Compared with respondents undergoing their initial screening mammographic examination, women who had undergone at least one prior screening examination reported that they were more likely to continue with screening if they had received a previous false-positive result (P = .02). Women younger than 60 years and those previously recalled were more willing to be called back more often for a noninvasive or, when indicated, an invasive procedure (P.05).A substantial fraction of women in this study would have preferred the inconvenience of and anxiety associated with a higher recall rate if it resulted in the possibility of detecting breast cancer earlier.

The purpose of this study was to develop and test a method for selecting "visually similar" regions of interest depicting breast masses from a reference library to be used in an interactive computer-aided diagnosis (CAD) environment. A reference library including 1000 malignant mass regions and 2000 benign and CAD-generated false-positive regions was established. When a suspicious mass region is identified, the scheme segments the region and searches for similar regions from the reference library using a multifeature based k-nearest neighbor (KNN) algorithm. To improve selection of reference images, we added an interactive step. All actual masses in the reference library were subjectively rated on a scale from 1 to 9 as to their "visual margins speculations". When an observer identifies a suspected mass region during a case interpretation he/she first rates the margins and the computerized search is then limited only to regions rated as having similar levels of spiculation (within +/-1 scale difference). In an observer preference study including 85 test regions, two sets of the six "similar" reference regions selected by the KNN with and without the interactive step were displayed side by side with each test region. Four radiologists and five nonclinician observers selected the more appropriate ("similar") reference set in a two alternative forced choice preference experiment. All four radiologists and five nonclinician observers preferred the sets of regions selected by the interactive method with an average frequency of 76.8% and 74.6%, respectively. The overall preference for the interactive method was highly significant (p < 0.001). The study demonstrated that a simple interactive approach that includes subjectively perceived ratings of one feature alone namely, a rating of margin "spiculation," could substantially improve the selection of "visually similar" reference images.

Our objective was to compare the performance and reproducibility of a computer-aided detection (CAD) scheme that uses multiple rotated and resampled images with an in-house-developed CAD scheme (single-image-based) and a commercial CAD product in detecting masses depicted on digitized mammograms.Ninety-two film mammograms (acquired from 23 patients) were selected. Forty-four mass regions associated with malignancy were visually identified. A commercial CAD system was used to scan and process each image four times, for a total of 368 digitized images depicting 176 mass regions. Images were processed using two CAD schemes developed in our laboratory. One uses the detection results generated from a single image, and the other averages five detection scores generated after processing the originally digitized image and four slightly rotated and resampled images. A region-based analysis was used to compare reproducibility and performance levels among the two in-house schemes and the commercial system.The commercial system detected a total of 98 mass regions (55.7% sensitivity) and 136 false-positive regions (an average of 0.37 per image). Among the detected mass regions, 76 represented 19 regions that were detected on all four scans and 22 represented 10 regions that were not fully reproducible. Eighty-eight false-positive detections represented 22 reproducible detections on all four scans. Our single-image-based scheme identified 87 mass regions and 160 false-positive regions. Seventeen mass regions and 28 false-positive regions were detected on all four scans. The multiple-image-based scheme identified 98 mass regions and 132 false-positive regions. Twenty-three mass regions were detected on all four scans. One hundred twelve of the 132 false-positive regions represented 28 reproducible detections.Averaging detection scores from multiple rotated and resampled images generated from a single digitization of a film can reduce variations in detection scores. Our multiple-image-based scheme improved both performance and reproducibility over the single-image-based scheme. The multiple-image-based scheme yielded an overall performance comparable to that of the commercial system but with improved reproducibility.

Rationale and Objectives The goal of mammography screening is to detect breast cancer at early stages, but because of the complexity of the breast parenchyma and the variability of signs of the disease, many cancers go unreported when initially visible on the mammogram. We compared the visual search strategy used by experienced mammographers in a case set where they examined both the mammogram in which a malignant mass was discovered at screening mammography and the most recent prior mammogram. Materials and Methods Four experienced mammographers participated in this experiment. They read a case set of 20 two-view mammograms, of which 15 contained a malignant mass and 5 were lesion-free, in two trials. For each of the cancer cases, two versions were shown to the observers: the one in which the cancer was reported in the clinical practice, called the “current” mammograms, and the most recent prior. Each trial had a balanced mix of current and prior mammograms. In addition, the same set of lesion-free cases was shown to the observers in both trials. The eye movements of the observers were tracked, and visual search parameters such as time to hit the location of the malignant mass, dwell, and mean pupil size in the location of the cancer were collected. Statistical analyses were used to determine whether there were differences between the current and prior mammograms. Results A total of 66% of the malignant masses in the current mammograms and 57% in the priors attracted some amount of visual attention. From these, 71% yielded a report on the current mammograms, but only 40% on the priors. In the cases where the observer saw the malignant mass, they did so within 2 seconds of image display, regardless of whether the mammogram was current or prior. Conclusion Most unreported malignant masses attracted some amount of visual attention, but it was in the processing of the information extracted in the location of the lesion that most errors occurred. In our experiment, approximately 70% of the total time used by the observers for visual scan of the cases was spent gathering information to corroborate the hypothesis already formed by the radiologist.

Rationale and objective To evaluate breast radiologists’ recognition of mammograms showing cancers that they correctly detected or “missed” during clinical interpretations. Materials and methods Two similar experiments were conducted. In the first, 33 bilateral screening mammograms were reviewed by four breast imagers. These included five cancers that each radiologist had detected, two cancers that each radiologist had “missed,” and five mammograms recalled by other radiologists that were not cancer. Radiologists were asked if they had interpreted the mammogram in clinic and if the mammogram was suspicious for cancer. In the second experiment, four different breast imagers reviewed 48 mammograms that included five cancers that each radiologist had detected, two cancers that each radiologist had “missed,” and five mammograms that were recalled by each radiologist but were not cancer. Using chi-square analysis, the performance of the radiologists on screening mammograms they had read in clinic was compared with their performance on mammograms read in clinic by other radiologists. Results Seven of eight radiologists did not remember interpreting any of the mammograms in clinic. One radiologist correctly remembered interpreting one mammogram in clinic, but interpreted it incorrectly. Average performance showed no significant difference (P = .60) between mammograms they had interpreted in clinic and those interpreted by others. Conclusion Radiologists do not remember most mammograms showing cancer that they have interpreted, either correctly or incorrectly, after they are mixed with mammograms showing cancer that were interpreted by other radiologists. Screening mammograms can be used in observer performance studies in which the interpreting radiologist participates as an observer.

Background Computer-aided mammography is rapidly gaining clinical acceptance, but few data demonstrate its actual benefit in the clinical environment. We assessed changes in mammography recall and cancer detection rates after the introduction of a computer-aided detection system into a clinical radiology practice in an academic setting. Methods We used verified practice- and outcome-related databases to compute recall rates and cancer detection rates for 24 Mammography Quality Standards Act-certified academic radiologists in our practice who interpreted 115,571 screening mammograms with (n = 59,139) or without (n = 56,432) the use of a computer-aided detection system. All statistical tests were two-sided. Results For the entire group of 24 radiologists, recall rates were similar for mammograms interpreted without and with computer-aided detection (11.39% versus 11.40%; percent difference = 0.09, 95% confidence interval [CI] = -11 to 11; P =.96) as were the breast cancer detection rates for mammograms interpreted without and with computer-aided detection (3.49% versus 3.55% per 1000 screening examinations; percent difference = 1.7, 95% CI = -11 to 19; P =.68). For the seven high-volume radiologists (i.e., those who interpreted more than 8000 screening mammograms each over a 3-year period), the recall rates were similar for mammograms interpreted without and with computer-aided detection (11.62% versus 11.05%; percent difference = -4.9, 95% CI = -21 to 4; P =.16), as were the breast cancer detection rates for mammograms interpreted without and with computer-aided detection (3.61% versus 3.49% per 1000 screening examinations; percent difference = -3.2, 95% CI = -15 to 9; P =.54). Conclusion The introduction of computer-aided detection into this practice was not associated with statistically significant changes in recall and breast cancer detection rates, both for the entire group of radiologists and for the subset of radiologists who interpreted high volumes of mammograms.

BACKGROUND The authors investigated the correlation between recall and detection rates in a group of 10 radiologists who had read a high volume of screening mammograms in an academic institution. METHODS Practice-related and outcome-related databases of verified cases were used to compute recall rates and tumor detection rates for a group of 10 Mammography Quality Standard Act (MQSA)-certified radiologists who interpreted a total of 98,668 screening mammograms during the years 2000, 2001, and 2002. The relation between recall and detection rates for these individuals was investigated using parametric Pearson (r) and nonparametric Spearman (rho) correlation coefficients. The effect of the volume of mammograms interpreted by individual radiologists was assessed using partial correlations controlling for total reading volumes. RESULTS A wide variability of recall rates (range, 7.7–17.2%) and detection rates (range, 2.6–5.4 per 1000 mammograms) was observed in the current study. A statistically significant correlation (P < 0.05) between recall and detection rates was observed in this group of 10 experienced radiologists. The results remained significant (P < 0.05) after accounting for the volume of mammograms interpreted by each radiologist. CONCLUSIONS Optimal performance in screening mammography should be evaluated quantitatively. The general pressure to reduce recall rates through “practice guidelines” to below a fixed level for all radiologists should be assessed carefully. Cancer 2004. © 2004 American Cancer Society.

We assessed and compared the benefit of using images acquired 1 year or 2 years previously during mammography interpretations.Eleven radiologists and one resident reviewed 128 cases three times: once without prior mammograms for comparison, once with mammograms from the most recent (1 year) examination, and once with mammograms acquired 2 years previously. They were asked to determine whether the patient should be recalled for additional procedures. Performances under the three conditions were compared.Radiologists were significantly more accurate (p0.001) when comparison mammograms (obtained 1 or 2 years previously) were available. Although sensitivity was not significantly affected between the availability of mammograms from 1 or 2 years earlier (p0.10), the specificity was. Specificity using mammograms from the latest examination (obtained 1 year previously) as a reference was significantly better (p = 0.03) than specificity using mammograms obtained 2 years previously.Comparison mammograms are important for accurate diagnosis-in particular, for increasing specificity. The latest prior examination seems to be the optimal one for this purpose.

We assessed the ability of technologists to accurately classify screening mammograms as either showing negative findings or requiring follow-up.In a prospective study, 33 technologists at a central facility and five satellite breast imaging facilities recorded whether mammograms obtained during 3019 examinations showed negative findings or findings that indicated that additional procedures were required. The technologists were not specifically trained for the experiment. The technologists' interpretations were compared with radiologists' interpretations.Technologists and radiologists agreed in 82% of the cases (77% negative findings and 5% requiring follow-up). Of the 175 cases recommended for follow-up by only the radiologists, 17 were ultimately biopsied and two were found to be malignant.Even without undergoing additional training, technologists can perform at reasonable levels of accuracy in classifying screening mammograms. The possibility of using technologists to group cases after the technologists have undergone training is an interesting concept that should be explored further.

Rationale and Objectives The authors assessed and compared the performance of a computer-aided detection (CAD) scheme for the detection of masses and microcalcification clusters on a set of images collected from two consecutive (“current” and “prior”) mammographic examinations. Materials and Methods A previously developed CAD scheme was used to assess two consecutive screening mammograms from 200 cases in which the current mammogram showed a mass or cluster of microcalcifications that resulted in breast biopsy. The latest prior examinations had been initially interpreted as negative or definitely benign findings (Breast Imaging Reporting and Data System rating, 1 or 2). The study involved images of 400 examinations acquired in 200 patients. Radiologists identified 172 masses and 128 clusters of microcalcifications on the current images. The performance of the CAD scheme was analyzed and compared for the current and latest prior images. Results There were significant differences (P Conclusion CAD schemes can detect a substantial fraction of masses and microcalcification clusters depicted on prior images. To improve performance with prior images, the scheme may have to be adaptively reoptimized with increasingly more subtle abnormalities.

To assess the performance of radiologists in the detection of masses and microcalcification clusters on digitized mammograms by using different computer-assisted detection (CAD) cuing environments.Two hundred nine digitized mammograms depicting 57 verified masses and 38 microcalcification clusters in 85 positive and 35 negative cases were interpreted independently by seven radiologists using five display modes. Except for the first mode, for which no CAD results were provided, suspicious regions identified with a CAD scheme were cued in all the other modes by using a combination of two cuing sensitivities (90% and 50%) and two false-positive rates (0.5 and 2.0 per image). A receiver operating characteristic study was performed by using soft-copy images.CAD cuing at 90% sensitivity and a rate of 0.5 false-positive region per image improved observer performance levels significantly (P.01). As accuracy of CAD cuing decreased so did observer performances (P.01). Cuing specificity affected mass detection more significantly, while cuing sensitivity affected detection of microcalcification clusters more significantly (P.01). Reduction of cuing sensitivity and specificity significantly increased false-negative rates in noncued areas (P.05). Trends were consistent for all observers.CAD systems have the potential to significantly improve diagnostic performance in mammography. However, poorly performing schemes could adversely affect observer performance in both cued and noncued areas.

To evaluate observers' ability to detect breast masses and clustered microcalcifications depicted on data compressed mammograms, an observer performance study was performed.Eight observers assessed 60 mammographic images obtained in six modes, ranging from noncompressed to a maximum data compression level of 101:1. Observers were asked to rate the images on a scale of 0 to 100 for the likelihood of the presence of a mass and also independently for the likelihood of the presence of clustered microcalcifications. In addition, observers were asked to rate their subjective assessment of the quality of each image for the detection of a mass and separately for the detection of microcalcifications. Receiver operating characteristic analyses were performed.The average area under the receiver operating characteristic curve, A(z), for the detection of clustered microcalcifications decreases significantly at the highest data compression level when compared with the noncompressed and two lowest levels of data compression (p0.01), and a trend test of the average area under the receiver operating characteristic curve for all observers is statistically significant (p0.05). No statistically significant differences among or between any of the data compression level modes for the detection of masses were detected.At a high level of mammogram data compression, observer performance was degraded for the detection of clustered microcalcifications. Detection of masses was not affected by the data compression methods and levels used in this study.

Purpose: To determine associations between radiologist-annotated MRI features and genomic measurements in breast invasive carcinoma (BRCA) from the Cancer Genome Atlas (TCGA). Methods: 98 TCGA patients with BRCA were assessed by a panel of radiologists (TCGA Breast Phenotype Research Group) based on a variety of mass and non-mass features according to the Breast Imaging Reporting and Data System (BI-RADS). Batch corrected gene expression data was obtained from the TCGA Data Portal. The Kruskal-Wallis test was used to assess correlations between categorical image features and tumor-derived genomic features (such as gene pathway activity, copy number and mutation characteristics). Image-derived features were also correlated with estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2/neu) status. Multiple hypothesis correction was done using Benjamini-Hochberg FDR. Associations at an FDR of 0.1 were selected for interpretation. Results: ER status was associated with rim enhancement and peritumoral edema. PR status was associated with internal enhancement. Several components of the PI3K/Akt pathway were associated with rim enhancement as well as heterogeneity. In addition, several components of cell cycle regulation and cell division were associated with imaging characteristics.TP53 and GATA3 mutations were associated with lesion size. MRI features associated with TP53 mutation status were rim enhancement and peritumoral edema. Rim enhancement was associated with activity of RB1, PIK3R1, MAP3K1, AKT1,PI3K, and PIK3CA. Margin status was associated with HIF1A/ARNT, Ras/ GTP/PI3K, KRAS, and GADD45A. Axillary lymphadenopathy was associated with RB1 and BCL2L1. Peritumoral edema was associated with Aurora A/GADD45A, BCL2L1, CCNE1, and FOXA1. Heterogeneous internal nonmass enhancement was associated with EGFR, PI3K, AKT1, HF/MET, and EGFR/Erbb4/neuregulin 1. Diffuse nonmass enhancement was associated with HGF/MET/MUC20/SHIP, and HGF/MET/RANBP9. Linear nonmass enhancement was associated with PIK3R1 and AKT activity. Conclusion: MRI-genomic association analysis revealed that several BRCA-associated gene features were associated with radiologist-annotated image features.

To compare the diagnostic performance of breast tomosynthesis versus supplemental mammography views in classification of masses, distortions, and asymmetries.Eight radiologists who specialized in breast imaging retrospectively reviewed 217 consecutively accrued lesions by using protocols that were HIPAA compliant and institutional review board approved in 182 patients aged 31-60 years (mean, 50 years) who underwent diagnostic mammography and tomosynthesis. The lesions in the cohort included 33% (72 of 217) cancers and 67% (145 of 217) benign lesions. Eighty-four percent (182 of 217) of the lesions were masses, 11% (25 of 217) were asymmetries, and 5% (10 of 217) were distortions that were initially detected at clinical examination in 8% (17 of 217), at mammography in 80% (173 of 217), at ultrasonography (US) in 11% (25 of 217), or at magnetic resonance imaging in 1% (2 of 217). Histopathologic examination established truth in 191 lesions, US revealed a cyst in 12 lesions, and 14 lesions had a normal follow-up. Each lesion was interpreted once with tomosynthesis and once with supplemental mammographic views; both modes included the mediolateral oblique and craniocaudal views in a fully crossed and balanced design by using a five-category Breast Imaging Reporting and Data System (BI-RADS) assessment and a probability-of-malignancy score. Differences between modes were analyzed with a generalized linear mixed model for BI-RADS-based sensitivity and specificity and with modified Obuchowski-Rockette approach for probability-of-malignancy-based area under the receiver operating characteristic (ROC) curve.Average probability-of-malignancy-based area under the ROC curve was 0.87 for tomosynthesis versus 0.83 for supplemental views (P.001). With tomosynthesis, the false-positive rate decreased from 85% (989 of 1160) to 74% (864 of 1160) (P.01) for cases that were rated BI-RADS category 3 or higher and from 57% (663 of 1160) to 48% (559 of 1160) for cases rated BI-RADS category 4 or 5 (P.01), without a meaningful change in sensitivity. With tomosynthesis, more cancers were classified as BI-RADS category 5 (39% [226 of 576] vs 33% [188 of 576]; P = .017) without a decrease in specificity.Tomosynthesis significantly improved diagnostic accuracy for noncalcified lesions compared with supplemental mammographic views.

The objective of our study was to assess the incidence of associated malignancy when microscopic radial scars and microscopic intraductal papillomas are encountered at percutaneous biopsy for lesions that otherwise reveal benign histopathology.A search of the pathology database for the period from December 14, 2006, through December 21, 2009, identified patients with a microscopic radial scar, a microscopic intraductal papilloma, or both at percutaneous biopsy. Patients whose percutaneous biopsy was performed for a lesion that revealed carcinoma or a high-risk pathology result were excluded to avoid confounding bias, as were patients who had only imaging follow-up. Only patients who underwent surgery solely for the study lesion were included. The lesion type that prompted core biopsy, biopsy guidance and device, sample number, and surgical outcomes were recorded. The incidences of benign, high-risk, and malignant pathology findings from surgery were calculated.The search revealed 35 patients (18 microscopic radial scars, 17 microscopic papillomas) who underwent surgery solely for the study lesion. Stereotactic guidance was used for 15 (43%); ultrasound, for 12 (34%); and MRI, for eight (23%). At surgery, 12 patients (34%) had high-risk histopathology results and 23 (66%) had benign results. No study lesions were upgraded to malignancy.Our study found no evidence of associated malignancy at surgical excision when microscopic radial scars and microscopic intraductal papillomas were encountered at percutaneous biopsy in patients who otherwise had benign histopathology results; thus, routine imaging follow-up may be performed.

Radial scar (RS) is characterized by a fibroelastic core with entrapped ducts and lobules. Association with carcinoma is not uncommon. There is some dilemma as to the need for excisional biopsy or follow-up after RS diagnosis on core biopsy.To determine the necessity of excisional biopsy after the diagnosis of benign RS by core biopsy.A total of 67 RS specimens associated with benign findings on core biopsy obtained between 2003 and 2008 were reviewed. They were grouped by their accompanying histopathologic features found upon subsequent surgical excision: benign, high-risk lesion (HRL), or carcinoma. Demographic features, radiologic findings, and needle gauge were compared within subgroups.After surgical excision, 15 (22.4%) patients in the benign group were upgraded to a HRL, 4 (5.9%) patients were upgraded to carcinoma, and 48 (71.6%) remained benign. We found that malignancy is associated with RS more frequently if the patient is older and postmenopausal. Other variables such as symptoms at presentation, presence and type of abnormality on mammography (Breast Imaging Reporting and Data System score), breast density, size of biopsy needle used, and number of core samples retrieved did not help to predict the presence of carcinoma.The HRL and cancer upgrade rate of RS, requiring further intervention such as surgery or chemoprevention, is 28% in this study. However, we found that age and menopausal status may be taken into consideration when making the decision to follow up or excise the RS diagnosed on core biopsy. There is insufficient data to support the predictive value of any variables. Therefore, RS associated with benign findings on core biopsy should be excised.

The aim of this study was to retrospectively compare the interpretive performance of synthetically reconstructed two-dimensional images in combination with digital breast tomosynthesis (DBT) versus full-field digital mammography (FFDM) plus DBT.Ten radiologists trained in reading tomosynthesis examinations interpreted retrospectively, under two modes, 114 mammograms. One mode included the directly acquired full-field digital mammograms combined with DBT, and the other included synthetically reconstructed projection images combined with DBT. The reconstructed images do not require additional radiation exposure. The two modes were compared with respect to sensitivity, namely, recommendation to recall a breast with either a pathology-proven cancer (n = 48) or a high-risk lesion (n = 6), and specificity, namely, no recommendation to recall a breast not depicting an abnormality (n = 144) or depicting only benign abnormalities (n = 30).The average sensitivity for FFDM with DBT was 0.826, compared to 0.772 for synthetic FFDM with DBT (difference, 0.054; P = .017 and P = .053 for fixed and random reader effects, respectively). The proportions of breasts with no or benign abnormalities recommended to be recalled were virtually the same: 0.298 and 0.297 for the two modalities, respectively (95% confidence intervals for the difference, -0.028 to 0.036 and -0.070 to 0.066 for fixed and random reader effects, respectively). Sixteen additional clusters of microcalcifications ("positive" breasts) were missed by all readers combined when interpreting the mode with synthesized images versus FFDM.Lower sensitivity with comparable specificity was observed with the tested version of synthetically generated images compared to FFDM, both combined with DBT. Improved synthesized images with experimentally verified acceptable diagnostic quality will be needed to eliminate double exposure during DBT-based screening.

The purpose of our study was to subjectively compare additional mammographic views to digital breast tomosynthesis (DBT) in the characterizing of known masses, architectural distortions, or asymmetries.Four experienced radiologists serially reviewed the imaging studies of 25 women with known masses, including full-field digital mammography (FFDM), additional views, and DBT. After review of the examinations, radiologists rated their relative preference in terms of classifying the finding in question when aided by the additional views versus aided by DBT, their combined diagnostic BI-RADS rating of the finding when both examinations were available, and whether or not they felt comfortable eliminating ultrasound in the specific cases being evaluated as a result of the DBT.FFDM and DBT (combined) were perceived to be better for diagnosis in 50% (50/100) of the ratings (25 cases x four readers = 100 ratings) compared with FFDM and additional diagnostic views. Over all readers, 92% of the ratings for verified cancer cases and 50% of the ratings for high-risk cases were rated as BI-RADS 4 or 5. In 12% (12/100) of the ratings, radiologists indicated that the availability of DBT would have eliminated the need for ultrasound as a part of the diagnostic process.DBT may be an alternative to obtaining additional mammographic views in most but not all cases of patients with a lesion that is not solely calcifications. In a fraction of cases, the use of DBT may eliminate the need for ultrasound.

Rationale and Objectives The aim of this study was to assess similarities and differences between methods of performance comparisons under binary (yes or no) and receiver-operating characteristic (ROC)–type pseudocontinuous (0–100) rating data ascertained during an observer performance study of interpretation of full-field digital mammography (FFDM) versus FFDM plus digital breast tomosynthesis. Materials and Methods Rating data consisted of ROC-type pseudocontinuous and binary ratings generated by eight radiologists evaluating 77 digital mammographic examinations. Overall performance levels were summarized with a conventionally used probability of correct discrimination or, equivalently, the area under the ROC curve (AUC), which under a binary scale is related to Youden's index. Magnitudes of differences in the reader-averaged empirical AUCs between FFDM alone and FFDM plus digital breast tomosynthesis were compared in the context of fixed-reader and random-reader variability of the estimates. Results The absolute differences between modes using the empirical AUCs were larger on average for the binary scale (0.12 vs 0.07) and for the majority of individual readers (six of eight). Standardized differences were consistent with this finding (2.32 vs 1.63 on average). Reader-averaged differences in AUCs standardized by fixed-reader and random-reader variances were also smaller under the binary rating paradigm. The discrepancy between AUC differences depended on the location of the reader-specific binary operating points. Conclusions The human observer's operating point should be a primary consideration in designing an observer performance study. Although in general, the ROC-type rating paradigm provides more detailed information on the characteristics of different modes, it does not reflect the actual operating point adopted by human observers. There are application-driven scenarios in which analysis based on binary responses may provide statistical advantages.

The purpose of this study was to compare in a retrospective observer study the diagnostic performance of full-field digital mammography (FFDM) with that of digital breast tomosynthesis.Eight experienced radiologists interpreted images from 125 selected examinations, 35 with verified findings of cancer and 90 with no finding of cancer. The four display conditions included FFDM alone, 11 low-dose projections, reconstructed digital breast tomosynthesis images, and a combined display mode of FFDM and digital breast tomosynthesis images. Observers rated examinations using the screening BI-RADS rating scale and the free-response receiver operating characteristic paradigm. Observer performance levels were measured as the proportion of examinations prompting recall of patients for further diagnostic evaluation. The results were presented in terms of true-positive fraction and false-positive fraction. Performance levels were compared among the acquisitions and reading modes. Time to view and interpret an examination also was evaluated.Use of the combination of digital breast tomosynthesis and FFDM was associated with 30% reduction in recall rate for cancer-free examinations that would have led to recall if FFDM had been used alone (p0.0001 for the participating radiologists, p = 0.047 in the context of a generalized population of radiologists). Use of digital breast tomosynthesis alone also tended to reduce recall rates, an average of 10%, although the observed decrease was not statistically significant (p = 0.09 for the participating radiologists). There was no convincing evidence that use of digital breast tomosynthesis alone or in combination with FFDM results in a substantial improvement in sensitivity.Use of digital breast tomosynthesis for breast imaging may result in a substantial decrease in recall rate.

Computerized determination of optimal search areas on mammograms for matching breast mass regions depicted on two ipsilateral views remains a challenge for developing multiview-based computer-aided detection (CAD) schemes. The purpose of this study was to compare three methods aimed at matching CAD-cued mass regions depicted on two views and the associated impact on CAD performance.The three search methods used (1) an annular (fan-shaped) band, (2) a straight strip perpendicular to the estimated centerline, and (3) a mixed search area bound on the chest wall side by a straight line and an annular arc on the nipple side, respectively. An image database of 200 examinations with positive results depicting the masses on two views and 200 examinations with negative results was used for testing. Two performance assessment experiments were conducted. The first investigated the maximum matching sensitivity as a function of the search area size, and the second assessed the change in CAD performance using these three search methods.To include all 200 paired mass regions within the search areas, maximum widths were 28 and 68 mm for the use of the straight strip and the annular band search methods, respectively. When applying a single-image-based CAD scheme to this image database, 172 masses (86% sensitivity) and 523 false-positive (FP) regions (0.33 per image) were detected and cued. Among the positive findings, 92 were cued by the CAD system on both views, and 80 were cued on only one view. In an attempt to match as many of the 172 CAD-cued masses (true-positive [TP] regions) on two views by incrementally reducing the CAD threshold inside the different search areas, the CAD scheme generated 158 TP-TP paired matches with 14 TP-FP paired matches, 142 TP-TP paired matches with 30 TP-FP paired matches, and 146 TP-TP paired matches with 26 TP-FP paired matches, using the methods involving the straight strip, the annular band, and the mixed search areas, respectively. Using the straight strip search method, the CAD also eliminated 25% of FP regions initially cued by the single-image-based CAD scheme and generated the lowest case-based FP detection rate, namely, 15% less than that generated by the annular band method.This study showed that among these three search methods, the straight strip method required a smaller search area and achieved the highest level of CAD performance.