Purpose: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. Materials and Methods: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. Results:Probability of malignancy-based mean AUCs for SM and FFDM images alone was 0.894 and 0.889, respectively (difference, 20.005; 95% confidence interval [CI]: 20.062, 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: 20.011, 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.

Purpose:To compare the diagnostic performance of breast tomosynthesis versus supplemental mammography views in classification of masses, distortions, and asymmetries. Materials and Methods: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. Results: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. Conclusion:Tomosynthesis significantly improved diagnostic accuracy for noncalcified lesions compared with supplemental mammographic views.

Tomosynthesis-based breast imaging may have great potential, but much work is needed before its optimal role in the clinical environment is known.

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.

Limiting the maximum number of cued regions per case can improve the overall case-based performance of computer-aided detection schemes in mammography.