Breast Cancer: Computer-aided Detection with Digital Breast Tomosynthesis.

PURPOSE: To evaluate a commercial tomosynthesis computer-aided detection (CAD) system in an independent, multicenter dataset. MATERIALS AND METHODS: Diagnostic and screening tomosynthesis mammographic examinations (n = 175; cranial caudal and mediolateral oblique) were randomly selected from a previous institutional review board-approved trial. All subjects gave informed consent. Examinations were performed in three centers and included 123 patients, with 132 biopsy-proven screening-detected cancers, and 52 examinations with negative results at 1-year follow-up. One hundred eleven lesions were masses and/or microcalcifications (72 masses, 22 microcalcifications, 17 masses with microcalcifications) and 21 were architectural distortions. Lesions were annotated by radiologists who were aware of all available reports. CAD performance was assessed as per-lesion sensitivity and false-positive results per volume in patients with negative results. RESULTS: Use of the CAD system showed per-lesion sensitivity of 89% (99 of 111; 95% confidence interval: 81%, 94%), with 2.7 ± 1.8 false-positive rate per view, 62 of 72 lesions detected were masses, 20 of 22 were microcalcification clusters, and 17 of 17 were masses with microcalcifications. Overall, 37 of 39 microcalcification clusters (95% sensitivity, 95% confidence interval: 81%, 99%) and 79 of 89 masses (89% sensitivity, 95% confidence interval: 80%, 94%) were detected with the CAD system. On average, 0.5 false-positive rate per view were microcalcification clusters, 2.1 were masses, and 0.1 were masses and microcalcifications. CONCLUSION: A digital breast tomosynthesis CAD system can allow detection of a large percentage (89%, 99 of 111) of breast cancers manifesting as masses and microcalcification clusters, with an acceptable false-positive rate (2.7 per breast view). Further studies with larger datasets acquired with equipment from multiple vendors are needed to replicate the findings and to study the interaction of radiologists and CAD systems.