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Objective For breast US interpretation, to assess impact of computer-aided diagnosis (CADx) in original mode or with improved sensitivity or specificity. Methods In this IRB approved protocol, orthogonal-paired US images of 319 lesions identified on screening, including 88 (27.6%) cancers (median 7 mm, range 1–34 mm), were reviewed by 9 breast imaging radiologists. Each observer provided BI-RADS assessments (2, 3, 4A, 4B, 4C, 5) before and after CADx in a mode-balanced design: mode 1, original CADx (outputs benign, probably benign, suspicious, or malignant); mode 2, artificially-high-sensitivity CADx (benign or malignant); and mode 3, artificially-high-specificity CADx (benign or malignant). Area under the receiver operating characteristic curve (AUC) was estimated under each modality and for standalone CADx outputs. Multi-reader analysis accounted for inter-reader variability and correlation between same-lesion assessments. Results AUC of standalone CADx was 0.77 (95% CI: 0.72–0.83). For mode 1, average reader AUC was 0.82 (range 0.76–0.84) without CADx and not significantly changed with CADx. In high-sensitivity mode, all observers’ AUCs increased: average AUC 0.83 (range 0.78–0.86) before CADx increased to 0.88 (range 0.84–0.90), P < 0.001. In high-specificity mode, all observers’ AUCs increased: average AUC 0.82 (range 0.76–0.84) before CADx increased to 0.89 (range 0.87–0.92), P < 0.0001. Radiologists responded more frequently to malignant CADx cues in high-specificity mode (42.7% vs 23.2% mode 1, and 27.0% mode 2, P = 0.008). Conclusion Original CADx did not substantially impact radiologists’ interpretations. Radiologists showed improved performance and were more responsive when CADx produced fewer false-positive malignant cues.

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.

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.

To assess interpretation performance and radiation dose when two-dimensional synthesized mammography (SM) images versus standard full-field digital mammography (FFDM) images are used alone or in combination with digital breast tomosynthesis images.A fully crossed, mode-balanced multicase (n = 123), multireader (n = 8), retrospective observer performance study was performed by using deidentified images acquired between 2008 and 2011 with institutional review board approved, HIPAA-compliant protocols, during which each patient signed informed consent. The cohort included 36 cases of biopsy-proven cancer, 35 cases of biopsy-proven benign lesions, and 52 normal or benign cases (Breast Imaging Reporting and Data System [BI-RADS] score of 1 or 2) with negative 1-year follow-up results. Accuracy of sequentially reported probability of malignancy ratings and seven-category forced BI-RADS ratings was evaluated by using areas under the receiver operating characteristic curve (AUCs) in the random-reader analysis.Probability of malignancy-based mean AUCs for SM and FFDM images alone was 0.894 and 0.889, respectively (difference, -0.005; 95% confidence interval [CI]: -0.062, 0.054; P = .85). Mean AUC for SM with tomosynthesis and FFDM with tomosynthesis was 0.916 and 0.939, respectively (difference, 0.023; 95% CI: -0.011, 0.057; P = .19). In terms of the reader-specific AUCs, five readers performed better with SM alone versus FFDM alone, and all eight readers performed better with combined FFDM and tomosynthesis (absolute differences from 0.003 to 0.052). Similar results were obtained by using a nonparametric analysis of forced BI-RADS ratings.SM alone or in combination with tomosynthesis is comparable in performance to FFDM alone or in combination with tomosynthesis and may eliminate the need for FFDM as part of a routine clinical study.

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 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 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.