Abstract

To determine if digital breast tomosynthesis (DBT) performs comparably to mammographic spot views (MSVs) in characterizing breast masses as benign or malignant. This IRB-approved, HIPAA-compliant reader study obtained informed consent from all subjects. Four blinded Mammography Quality Standards Act-certified academic radiologists individually evaluated DBT images and MSVs of 67 masses (30 malignant, 37 benign) in 67 women (age range, 34-88 years). Images were viewed in random order at separate counterbalanced sessions and were rated for visibility (10-point scale), likelihood of malignancy (12-point scale), and Breast Imaging Reporting and Data System (BI-RADS) classification. Differences in mass visibility were analyzed by using the Wilcoxon matched-pairs signed-ranks test. Reader performance was measured by calculating the area under the receiver operating characteristic curve (A(z)) and partial area index above a sensitivity threshold of 0.90 (A(z)(0.90)) by using likelihood of malignancy ratings. Masses categorized as BI-RADS 4 or 5 were compared with histopathologic analysis to determine true-positive results for each modality. Mean mass visibility ratings were slightly better with DBT (range, 3.2-4.4) than with MSV (range, 3.8-4.8) for all four readers, with one reader's improvement achieving statistical significance (P = .001). The A(z) ranged 0.89-0.93 for DBT and 0.88-0.93 for MSV (P ≥ .23). The A(z)((0.90)) ranged 0.36-0.52 for DBT and 0.25-0.40 for MSV (P ≥ .20). The readers characterized seven additional malignant masses as BI-RADS 4 or 5 with DBT than with MSV, at a cost of five false-positive biopsy recommendations, with a mean of 1.8 true-positive (range, 0-3) and 1.3 false-positive (range, -1 to 4) assessments per reader. In this small study, mass characterization in terms of visibility ratings, reader performance, and BI-RADS assessment with DBT was similar to that with MSVs. Preliminary findings suggest that MSV might not be necessary for mass characterization when performing DBT.

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