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WOS:000704610500004 ESCI PubMed ID34651109 Objective: The purpose of this study was to look into the relationship between breast size and mammographic breast density in women and breast radiation dose on full-field digital mammography (FFDM), as well as the factors that influence radiation dose. Materials and Methods: The study included a total of 2,060 FFDM images from 515 consecutive participants. The participants were divided into two groups: those exposed to high doses (>3 mGy) and those exposed to low doses (

We constructed a mammography database of 807 Japanese women and 2,772 images obtained using five commercial full-field digital mammography (FFDM) devices at four different facilities. Five types of mammography devices fabricated by four manufacturers were used: one with a Mo target (AMULET F), one with Mo and Rh targets (Senographe DS), one with Mo and W targets (AMULET), and two with a W target (MAMMOMAT Fusion and Selenia Dimensions). The purpose of this study was to focus on the mean glandular dose (MGD) in the database and analyze the difference in the MGD of Japanese women radiographed by mammographic devices with different targets or target/filter combinations. Furthermore, we clarify the difference between the displayed and measured MGDs for the three types of mammography devices. The average compression pressure and compression breast thickness of the Japanese women in the mammography in this study were 90.9±21.7 N and 43.3±12.9 mm, respectively. The breast compression pressure slightly varied depending on the facility or FFDM device, while the compression breast thickness decreased with the increase in the compression pressure for all FFDM devices. Differences in breast compression thickness existed depending on the mammography devices. The MGDs of the two types of mammography devices using the W target were smallest (1.335±0.358, 1.218±0.464 mGy). The displayed and measured MGDs of the three types of FFDM devices had a good correlation. However, the difference between the displayed and measured MGDs of the two devices increased with the MGD.

Background Although several studies proved that SM could substitute for FFDM, the efficacy of SM in microcalcification evaluation remains controversial. Aims To investigate the diagnostic performance of synthetic mammography (SM) in the evaluation of microcalcifications in comparison with full-field digital mammography (FFDM). Methods In this retrospective study, 76 mammograms of 76 patients who underwent FFDM and digital breast tomosynthesis (DBT) acquisitions concomitantly between 2018 and 2019 and whose final mammography interpretation revealed microcalcifications (28 malignant microcalcifications and 48 benign microcalcifications) were included. All mammograms were reviewed independently by three radiologists with different levels of breast imaging experience. Readers were blinded to patient outcomes and interpreted each case in two separate reading sessions (first FFDM, second SM + DBT), according to the BI-RADS lexicon. The area under the receiver operating characteristic (ROC) curve (AUC) was calculated using ROC analysis in all cases for FFDM and SM + DBT sessions. The readers also assigned conspicuity scores to mammograms. The interobserver agreement was calculated using intraclass correlation coefficients (ICC). Results The overall AUCs for malignant microcalcifications were 0.80 (95% CI: 0.75-0.85) in FFDM and 0.85 (95% CI: 0.80-0.89) in SM, and no significant difference was found between the groups (p = 0.0603). The sensitivity of the readers increased slightly with experience. The ICC values of BI-RADS categorization between readers were 0.93 (95% CI: 0.90-0.95) and 0.94 (95% CI: 0.91-0.96) for FFDM and SM, respectively. Conclusions SM had similar diagnostic performance in the evaluation of breast microcalcifications in comparison with FFDM, regardless of reader experience levels.

Objective To compare lesion conspicuity on synthetic screening mammography (SM) plus digital breast tomosynthesis (DBT) versus full field digital mammography (FFDM) plus DBT. Materials and methods Seven breast imagers each prospectively evaluated 107–228 screening mammograms (FFDM, DBT, and SM; total 1206 examinations) over 12 weeks in sets of 10–50 consecutive examinations. Interpretation sessions alternated as follows: SM + DBT, then FFDM, or FFDM + DBT, then SM. Lesion conspicuity on SM versus FFDM (equal/better versus less) was assessed using proportions with 95% confidence intervals. DBT-only findings were excluded. Results Overall 1082 of 1206 (89.7%) examinations were assessed BI-RADS 1/2, and 124 of 1206 (10.3%) assessed BI-RADS 0. There were 409 evaluated findings, including 134 masses, 119 calcifications, 72 asymmetries, 49 architectural distortion, and 35 focal asymmetries. SM conspicuity compared to FFDM conspicuity for lesions was rated 1) masses: 77 (57%) equal or more conspicuous, 57 (43%) less conspicuous; 2) asymmetries/focal asymmetries: 61 (57%) equal or more conspicuous, and 46 (43%) less conspicuous; 3) architectural distortion: 46 (94%) equal or more conspicuous, 3 (6%) less conspicuous; 4) calcifications: 115 (97%) equal or more conspicuous, 4 (3%) less conspicuous. SM had better conspicuity than FFDM for calcifications and architectural distortion and similar conspicuity for most masses and asymmetries. Conclusion Compared to FFDM, SM has better conspicuity for calcifications and architectural distortion and similar conspicuity for most masses and asymmetries.

Background Mammography has been the mainstay for the detection of breast cancer over decades. It has gradually advanced from screen film to full-field digital mammography. Tomosynthesis has evolved as advanced imaging for early diagnosis of breast lesions with a promising role in both diagnostic and screening settings, particularly in dense and treated breasts. Results This study included 90 female patients according to our inclusion criteria. All patients perform full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) and were classified according to breast density and age groups. Breast imaging reporting and data system (BI-RADS) scoring was assigned for each case. This was correlated with the final diagnosis; the diagnostic indices of mammography were a sensitivity of 64.44%, a specificity of 77.78%, a positive predictive value (PPV) 74.63%, a negative predictive value (NPV) of 68.63%, and a diagnostic accuracy of 71.11%. Diagnostic indices of DBT were a sensitivity of 100%, a specificity of 97.77%, PPV 97.78%, NPV 100%, and diagnostic accuracy of 97.7%. In patients with dense breasts American College of Radiology (ACR) (c and d), 61% of cases had changed their BIRADS scoring with the addition of tomosynthesis. Yet, in non-dense breast ACR (a and b), 45% of cases had changed BIRADS scoring with the addition of DBT to FFDM. Conclusion DBT is a promising imaging modality offering better detection and characterization of different breast abnormalities, especially in young females, and those with dense breasts with an increase of sensitivity and specificity than FFDM. This leads to a reduction in the recalled cases, negative biopsies, and assessing the efficacy of therapy as it enables improving detection of breast cancer and different breast lesions not visualized by conventional mammography

Objective The aim: Comparing sensitivity and specificity of digital breast tomosynthesis and full-field digital mammography in breast cancer detection associated with four different types of asymmetries according to BI-RADS Atlas. Patients and methods Materials and methods: Study included 201 patients with four types of asymmetries according BI-RADS atlas (asymmetry - 81 (40,3%), focal asymmetry - 82 (40,8%), global asymmetry - 36 (17,9%) and developing asymmetry - 2 (1,0%)) who underwent full-field digital mammography, digital breast tomosynthesis and hand-held full breast ultrasound from January 2017 to June 2018. The general rate of breast cancer for the 201 patients with asymmetries was 8 cases (4,0%) (IBC, n=6 (3,0%); DCIS, n=2 (1,0%) other findings associated with asymmetries were non-malignant, n=10 (5,0%) (sclerosing adenosis, n=5 (2,5%); fibroadenomatosis, n=3 (1,5%); simple cyst, n=1 (0,5%); radial scar associated with papilloma, typical ductal hyperplasia and sclerosing adenosis, n=1 (0,5%). Results Results: Analysis of the results showed that sensitivity of digital breast tomosynthesis was 75.0% [95% CI, 34.91% to 96.81%] and specificity was 94.8% [95% CI, 90.68% to 97.49%] which was superior to full-field digital mammography sensitivity 50.0% [95% CI, 15.70% to 84.30%] and specificity 91.19% [95% CI, 86.27% to 94.78%] for breast cancer detection associated with different types of asymmetries. Conclusion Conclusions: Using of digital breast tomosynthesis in assessment of breast asymmetries can improve sensitivity and specificity in breast cancer detection and reduce number of unnecessary biopsies and short-interval follow-up examinations.

Mammograms are the mainstay of diagnostic breast imaging and cancer screening. Despite advances in technology such as Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT), these imaging techniques are purely structural, and are unable to overcome shortcomings in mammography posed by dense breast parenchyma. Magnetic Resonance Imaging (MRI) is the most sensitive modality in breast imaging, due to its functional aspects in addition to structural imaging with this modality. The use of MRI is however constrained by cost and availability. The utilization of intravenous contrast with mammograms introduces a functional element to imaging. This greatly improves the sensitivity of the examination, approaching sensitivity levels of Magnetic Resonance Imaging (MRI) in the detection of primary breast cancer. With increased sensitivity afforded by assessment of tumor neo-vascularity, as well as its low cost, low energy imaging that is more readily available than MRI, Contrast-Enhanced Mammography (CEM) if more readily available than MRI, this imaging modality is a potential game-changer in breast imaging. In this article, we share our experience in the use of CEM, for indications previously reserved for MRI, with the literature review of these indications. In resonance with prior studies, we echo the ease of performing and reporting of CEM as well as greater patient comfort as the distinct advantages of CEM. In spite of slightly higher radiation dose and some risks related to contrast media, functional results at a significantly lower cost may change how we practice breast imaging in the future using CEM.

Background: Mammography is acknowledged as the single most effective method of screening for breast cancer and is credited with helping to reduce breast cancer mortality by approximately 30%. CAD systems are a new tool in detecting breast cancers on screening mammograms and in detecting potentially suspicious abnormalities on a mammogram. The aim & objective is to main aim of the present study to evaluate the performance of Computer Aided Detection using Full Field Digital Mammography in Breast Cancer imaging. Subjects and Methods:In the present study, Cases with lump breast with clinical suspicion of breast cancer and post op recurrence of breast cancer were imaged with FFDM and images were read on the viewing monitor without and with the aid of CAD software. The present study confirms that the diagnosis of breast cancer is made only following histopathology of respected specimen. Results: The maximum incidence was in 41-50 years and 51-60 years which was 13 cases in each group (30 %). There were 25 cases out of 40 (62.5%) in which the lesion was marked by CAD. Out of which in 20 cases (50%) only one lesion was marked by CAD and in 4 cases (10%) two lesions were marked by CAD. The total number of lesions marked by CAD was 25 (62.5%). Majority of patients had scattered fibro glandular density of breast. This was present in 19 patients (47.5%). 10 patients (20%) had heterogeneously dense breast, 07 patients (17.5%) had fatty breast and 04 patients (10%) had extremely dense breast. In majority of cases the lesion type was mass alone which was present in 26 cases (60%). While 10 cases (25%) presented as mass with microcalcifications and 4 cases (10%) presented with microcalcifications alone. In 24 cases there was no spread of cluster of micro calcification (60%). In 7 cases (17.5%) the spread of cluster of micro calcification was 40mm. In majority of cases the HPE revealed DCIS which was seen in 22 cases (55%), 08 cases (20%) were invasive ductal carcinoma and 02 cases was invasive lobular carcinoma. In 22 cases (55%) the BIRADS for the breast affected with cancer was BIRADS-V. While in 14 cases (35%) the score was BIRADS-IV, 04 cases (10%) the score was BIRADS-VI and in 02 case (5%) the score was BIRADS-III. The sensitivity, specificity and accuracy of CAD for detection of mass were 70%, 100% and 85% respectively and for detection of cluster of microcalcification were 100% respectively. Conclusion: CAD with FFDM is good at detection of Microcalcifications. Detection of masses is better without the aid of CAD as compared to CAD. However detection of lesion improves if reading of mammogram is done both with and without CAD.

Introduction To investigate compliance to the ‘30% rule’ and key factors which may influence visualisation of the pectoralis major muscle (PMM) on the craniocaudal (CC) view of the breast. Methods A retrospective review of 2688 paired full‐field digital mammography (FFDM) CC view mammograms of women attending BreastScreen NSW between August and October 2015 was undertaken. PMM visualisation and measurements of PMM width and length, compressed breast thickness, the posterior nipple line (PNL) and age were recorded. Statistical analysis was performed using descriptive and inferential statistics to investigate associations between key breast measurements, age and PMM visualisation. Results PMM visualisation was reported in 10.4% of images unilaterally (one breast, left or right only), 14.1% bilaterally (both left and right breasts) and 24.5% overall (unilateral and bilateral combined). There was little or no correlations between PMM length or width and age, breast compressed thickness or PNL. Multiple logistic regression analysis found that up to 15% of the variance in visualisation of the PMM was accounted for by the predictors overall. While some predictors provided a statistically significant contribution to the model, the contribution was small and the odds ratio for all predictors approximated 1. Conclusion This research could not replicate the ‘30% rule’, and visualisation of the PMM was determined not to be influenced by the variables investigated. The significance of the ‘rule’ itself must be challenged where the vast majority of images (70–85%) do not comply, and there is no requirement for repeat imaging if the ‘rule’ is not met. Further research should be undertaken to validate this study including analysis of diagnostic images for comparison., The ‘30% rule’ was first documented 27 years ago, in the film screen era, by Bassett et al., establishing that the pectoralis major muscle (PMM) was able to be visualised in 32% of craniocaudal breast images. Subsequently, a wide range of visualisation rates (11–48%) has been cited. This study reports that the ‘30% rule’ is not being achieved in the Australian digital screening setting. The overall visualisation rate of the PMM was 24.5% with only 14.1% of images depicting the PMM bilaterally. No significant associations between PMM visualisation and age, compressed breast thickness or breast size were identified.

Introduction There are increasing concerns about radiation exposure among women who undergo full‐field digital mammography (FFDM) and digital breast tomosynthesis (DBT). The main aim of this study was to compare the entrance surface dose (ESD) and average glandular dose (AGD) from FFDM and DBT for different breast thicknesses. Methods The ESD and AGD for FFDM in craniocaudal, mediolateral oblique and DBT in craniocaudal projection were recorded from a GE Senographe Essential FFDM unit. The accuracy of the ESD and AGD from the FFDM unit was verified during regular quality assurance programme. Patients were categorised according to their compressed breast thicknesses. X‐ray tube potential and target filter combinations were varied with ESD and AGD recorded directly from the FFDM unit. The non‐parametric Kruskal–Wallis, Mann–Whitney and Wilcoxon signed‐rank tests were performed. Results The median and interquartile range (IQR) age of the patients were 48 and 11 years, respectively. The highest median for ESD and median total AGD for different breast thicknesses were ranged from 3.3 to 9.1 mGy and 3.3 to 6.0 mGy, respectively, for two‐view FFDM. However, it ranged from 3.1 to 8.9 mGy and 1.8 to 4.0 mGy, respectively, for single‐view DBT. Both ESD and AGD were significantly lower for DBT (P, There are some concerns about increasing the radiation dose among women undergoing both full‐field digital mammography (FFDM) and digital breast tomosynthesis (DBT). In our study, we found that the entrance skin dose (ESD) and total average glandular dose (AGD) are lower in DBT than FFDM techniques. This offers opportunities for the implementation of DBT in the breast cancer detection.

To evaluate conspicuity of screen-detected cancers on two-dimensional synthetic mammography (SM) reconstructed from digital breast tomosynthesis (DBT) compared to two-dimensional full field digital mammography (FFDM).IRB-approved retrospective review of consecutive screen-detected cancers from October 1, 2015 to June 30, 2017 was performed. All examinations were reviewed by three radiologists in consensus (n = 224); a score of 1-3 was given to each screen-detected cancer on SM vs. FFDM [1 = FFDM more conspicuous than SM, 2 = FFDM equivalent to SM, and 3 = SM more conspicuous than FFDM]. Findings considered only visible on tomosynthesis (n = 40), without medical history (n = 2), and with skin thickening only (n = 1) were excluded, leaving 181 cases as the study population. The longitudinal medical record was reviewed to determine patient demographics and outcomes of imaging surveillance and biopsy.Mammographic features on SM (n = 181) were calcifications (n = 68, 37.8%), masses (n = 51, 27.8%), asymmetries (n = 50, 27.6% [11 focal asymmetries]), and distortion (n = 12, 6.8%). The majority (76%, 137/181) of findings were equal or more conspicuous on SM vs. FFDM. However, calcifications and distortion greater than 2 cm were more conspicuous on SM and asymmetries were less conspicuous on SM vs. FFDM, controlling for menopausal status, family or personal history of breast cancer, BRCA status, and breast density.Although the majority of screen-detected cancers are equal to more conspicuous on SM when compared to FFDM, calcifications and asymmetries2cm were less conspicuous on SM than FFDM. When SM + DBT is used as an alternative to FFDM + DBT in breast cancer screening, caution should be taken when assessing one-view asymmetries and findings2cm on SM.

Objective: To assess the average glandular doses (AGD) from full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT). Material and Methods: Radiographic exposure parameters target/filter, tube voltage, and tube current were collected from 50 patients. Patient information including age, breast thickness, entrance surface air kerma (ESAK) and AGD from the monitor display were also recorded. The tube outputs (tube voltage and tube loadings) at the reference points in both FFDM and DBT modes were measured. The AGD was calculated from ESAK by using the correction factors following the Technical Report Series no. 457 protocol. For the DBT mode, the AGD was calculated and corrected for the X-ray gantry rotation following the Dance et al. method. Results: The radiation doses to breasts in terms of ESAK and AGD from FFDM were 4.97±2.29 and 1.36±0.48 milligray (mGy) respectively. The third quartiles were 6.5 mGy and 1.67 mGy, findings which were lower than the standard Dose Reference Levels reported by the International Atomic Energy Agency recommendation (AGD 3 mGy/view for standard breast thickness with grid). For the DBT mode, ESAK and AGD were 6.49±2.10 mGy and 1.63±0.51 mGy. The third quartiles were 7.68 mGy and 1.81 mGy which were more than the FFDM mode by 23.0% and 17.0%, respectively. Conclusion: This study found that the AGD received from the DBT mode was higher than from the FFDM mode. Patients who underwent combination modes of mammographic examination increasingly received AGD up to 1.74 mGy. However, the AGD in our institute was still lower than the standard AGD recommendations.

Objective: To date, few studies have compared the diagnostic performance and visibility of microcalcifications obtained using digital breast tomosynthesis (DBT) with those obtained from full-field digital mammography (FFDM). The visualization and characterization of microcalcifications with DBT remain controversial. The purpose of this study was to compare the visibility of microcalcifications and determine whether DBT exhibits a diagnostic advantage for visualizing microcalcifications over FFDM. Methods: We retrospectively reviewed 120 cases including DBT and FFDM imaging (60 histologically verified as breast cancers and 60 as benign microcalcifications or normal). DBT images with a wide scan-angle of 50° and FFDM images were obtained using a flat-panel system (MAMMOMAT Inspiration, Siemens). Images were independently reviewed by four board-certified radiologists and evaluated for the presence of microcalcifications, probability of malignancy (BI-RADS classification), and visibility. Results: In predicting the malignancy of detected microcalcifications, no significant difference was found between readers’ areas under the receiver operating characteristic curve for DBT and FFDM (p = 0.068). The visibility scores of detected microcalcifications were 3.74 ± 1.06 for DBT and 3.46 ± 0.93 for FFDM, respectively. The visibility of microcalcifications when using DBT was found to be significantly superior to that of FFDM (p < 0.05). Conclusion: Our results suggest that the image quality of DBT with a wide scan-angle is comparable or superior to that obtained with FFDM in terms of both visibility and assessment of microcalcifications.

To investigate whether digital breast tomosynthesis (DBT) and subsequently generated synthesized mammography (SM) images show a better performance than full-field digital mammography (FFDM) images for diagnosing malignant breast lesions. In addition, the radiation doses for SM using different procedures were compared. This prospective study enrolled 212 women (age ≥ 25 years) with clinically suspicious breast lesions. All participants underwent FFDM and DBT with the same breast compression. Finally, 222 lesions were confirmed by pathological analysis. The mammogram results were evaluated according to the BI-RADS criteria and compared with the pathological results. The diagnostic performances, morphological features and average glandular doses (AGDs) were compared. In total, 141 malignant lesions and 81 benign lesions were confirmed by pathological analysis. The overall AGD showed no significant difference between FFDM and DBT. Compared with 2D imaging, the AUC values of FFDM plus DBT and SM plus DBT were both significantly different overall (P = 0.0002) and remained significantly different in dense breasts (P

Purpose The advent of three-dimensional breast imaging systems such as digital breast tomosynthesis (DBT) has great promise for improving the detection and diagnosis of breast cancer. With these new technologies comes an essential need for testing methods to assess the resultant image quality. Although randomized clinical trials are the gold standard for assessing image quality, phantom-based studies can provide a simpler and less burdensome approach. In this work, a complete framework is presented for task-based evaluation of microcalcification (MCs) detection performance for DBT imaging systems. Methods The framework consists of three parts. The first part is a realistic anthropomorphic physical breast phantom created through inkjet printing, with parchment paper and iodine-doped ink. The second is a method for inserting realistic MCs fabricated from calcium hydroxyapatite. The reproducibility and stability of the phantom materials were investigated through multiple samples of parchment and ink over 6 months. The final part is an analysis using a four-alternative forced choice (4AFC) reader study. To demonstrate the framework, a task-based 4AFC study was conducted using a clinical system to compare performance from DBT, synthetic mammography (SM), and full-field digital mammography (FFDM). Nine human observers read images containing MC clusters imaged with all three modalities and tried to correctly locate the MCs. The proportion correct (PC) was measured as the number of correctly detected clusters out of all trials. Results Overall, readers scored the highest with FFDM, (PC = 0.95 ± 0.03) then DBT (0.85 ± 0.04), and finally SM (0.44 ± 0.06). For the parchment and ink samples, the linear attenuation properties were very stable over 6 months. In addition, little difference was found between the various parchment and ink samples, indicating good reproducibility. Conclusions This framework presents a promising methodology for evaluating diagnostic task performance of clinical breast DBT systems.

Currently in diagnostic setting for breast cancer, FFDM and DBT are performed conjunctively. However, performing two imaging modalities may increase radiation exposure by double. Two-dimensional reconstructed images created from DBT with 2DSM, has a potential to replace conventional FFDM in concerning both radiation dosage and image quality. With increasing concerns for individual radiation exposure, studies analyzing radiation dosage in breast imaging modalities are needed. This study compared radiation dosage and image quality between DBT + 2DSM versus FFDM.374 patients (mean age 52 years) who underwent both DBT and FFDM were retrospectively reviewed. Radiation dosage data were obtained by radiation dosage scoring and monitoring program Radimetrics (Bayer HealthCare, Whippany, NJ). Entrance dose and mean glandular doses in each breast were obtained for both modalities. To compare image quality of DBT + 2DSM and FFDM, a 5-point scoring system for lesion clarity was assessed. The parameters of radiation dosage (entrance dose, mean glandular dose) and image quality (lesion clarity scoring) were compared.For entrance dose, DBT had lower mean dosage (14.8 mGy) compared with FFDM (21.8 mGy, p-value 0.0001). Mean glandular doses for both breasts were lower in DBT (Left 1.74, Right 2.1) compared with FFDM (Left 2.85, Right 2.74, p-value 0.0001). Lesion clarity score was higher in DBT with 2DSM (mean score 4.03) compared with FFDM (3.82, p-value 0.0001).DBT showed lower radiation entrance dose and mean glandular doses to both breasts compared with FFDM. DBT + 2DSM had better image quality than FFDM, suggesting that DBT with 2DSM has potential as an alternative to FFDM.

Synthesized 2D images can be reconstructed from tomosynthesis images in breast imaging. This study aims to investigate the diagnostic efficacy of synthesized 2D images (C-View) in comparison to full field digital mammography (FFDM) when used with digital breast tomosynthesis (DBT) in multi-ethnic Malaysian population. FFDM and C-View images (n = 380) were independently evaluated by three readers through Breast Imaging Reporting and Data System (BI-RADS) categorisation, breast density and lesion characterisation. Statistical analysis was done comparing sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of C-View + DBT with FFDM + DBT as standard of reference. Very good interreader agreement in BI-RADS category and density assessment between C-View + DBT and FFDM + DBT, with high sensitivity, specificity, PPV and NPV of C-View + DBT when compared with FFDM + DBT. There was comparable PPV between C-View + DBT and FFDM + DBT, with histopathology as gold standard. High level of interreader agreement in BI-RADS category and density assessment for FFDM + DBT and C-View + DBT. There was good agreement between FFDM + DBT and C-View + DBT in mass characterization, and almost perfect agreement in calcification and asymmetric density. 52.2% lower radiation dose incurred when using C-View + DBT. Hence, synthesized 2D images are comparable to FFDM with reduction in radiation dose within the limits of Malaysian multi-ethnic population.

Rationale and Objectives Synthesized mammography with digital breast tomosynthesis (SM+DBT) and full-field digital mammography with DBT were prospectively evaluated for recall rate (RR), cancer detection rate (CDR), positive predictive value 1 (PPV1), lesion recall differences, and disagreements in recall for additional imaging. Materials and Methods From December 15, 2015 to January 15, 2017, after informed consent was obtained for this Health Insurance Portability and Accountability Act compliant study, each enrolled patient's SM+DBT and FFDM+DBT were interpreted sequentially by one of eight radiologists. RR, CDR, PPV1, and imaging findings (asymmetry, focal asymmetry, mass, architectural distortion, and calcifications) recalled were reviewed. Results For SM+DBT and FFDM+DBT in 1022 patients, RR was 7.3% and 7.9% (SM+DBT vs. FFDM+DBT: diff= −0.6%; 90% CI= −1.4%, 0.1%); CDR was 6.8 and 7.8 per 1000 (SM+DBT vs. FFDM+DBT: diff= −1.0, 95% CI= −5.5, 2.8, p = 0.317); PPV1 was 9.3% and 9.9% (relative positive predictive value for SM+DBT vs. FFDM+DBT: 0.95, 95% CI: 0.73–1.22, p = 0.669). FFDM+DBT detected eight cancers; SM+DBT detected seven (missed 1 cancer with calcifications). SM+DBT and FFDM+DBT disagreed on patient recall for additional imaging in 19 patients, with majority (68%, 13/19 patients) in the recall of patients for calcifications. For calcifications, SM+DBT recalled six patients that FFDM+DBT did not recall, and FFDM+DBT recalled seven patients that SM+DBT did not recall, even though the total number of calcifications finding recalled was similar overall for both SM+DBT and FFDM+DBT. Conclusion Disagreement in recall of patients for calcifications may impact cancer detection by SM+DBT, warranting further investigation.

Randomized, Controlled Trials (RCT), the most rigorous tests of efficacy, had proven that mammography screening reduces deaths by early detection. This had been validated in studies that showed that screening in the community also resulted in fewer deaths. Film mammography (FM) had been replaced by Xeroradiography (XM) which had been replaced by Screen/Film Mammography (SFM) which was being replaced by Full Field Digital Mammography (FFDM). The FDA required FFDM to undergo a Premarket Approval (PMA) instead of the usual 510 K required for conversion for other x-ray studies to digital imaging. In addition, the FDA was going to require that even after a PMA, the FFDM systems were going to have to undergo a post approval RCT comparison to SFM. Experience and science were able to convince the FDA that a post-approval trial was not needed, and the requirement was dropped. Congress, however, had earmarked $25 million to support the trial that was no longer required. It appears that the Digital Mammographic Imaging Screening Trial (DMIST) was undertaken to take advantage of the earmarked money and was used to compare SFM to FFDM for cancer detection. The historical issues involved with DMIST provide an important background for the Tomosynthesis Mammographic Imaging Screening Trial (TMIST). Just as the monies for DMIST could have been better spent on an RCT of MRI for screening, the monies for TMIST could be better spent to improve our ability to detect more breast cancers at a time in their growth when cure may be possible.

The presence of round cystic and solid mass lesions identified at mammogram screenings account for a large number of recalls. These recalls can cause undue patient anxiety and increased healthcare costs. Since cystic masses are nearly always benign, accurate classification of these lesions would be allow a significant reduction in recalls. This classification is very difficult using conventional mammogram screening data, but this study explores the possibility of performing the task on dual-energy full field digital mammography (FFDM) data. Since clinical data of this type is not readily available, realistic simulated data with different sources of variation are used. With this data, a deep convolutional neural network (CNN) was trained and evaluated. It achieved an AUC of 0.980 and 42% specificity at the 99% sensitivity level. These promising results should motivate further development of such imaging systems.