Abstract

This study aimed to compare Breast Imaging Reporting and Data System (BI-RADS) assessment of lesions in two-view digital mammogram (DM) to two-view wide-angle digital breast tomosynthesis (DBT) without DM. With Institutional Review Board approval and written informed consent, two-view DBTs were acquired from 134 subjects and the corresponding DMs were collected retrospectively. The study included 125 subjects with 61 malignant (size: 3.9-36.9 mm, median: 13.4 mm) and 81 benign lesions (size: 4.8-43.8 mm, median: 12.0 mm), and 9 normal subjects. The cases in the two modalities were read independently by six experienced Mammography Quality Standards Act radiologists in a fully crossed counterbalanced manner. The readers were blinded to the prevalence of malignant, benign, or normal cases and were asked to assess the lesions based on the BI-RADS lexicon. The ratings were analyzed by the receiver operating characteristic methodology. Lesion conspicuity was significantly higher (P << .0001) and fewer lesion margins were considered obscured in DBT. The mean area under the receiver operating characteristic curve for the six readers increased significantly (P = .0001) from 0.783 (range: 0.723-0.886) for DM to 0.911 (range: 0.884-0.936) for DBT. Of the 366 ratings for malignant lesions, 343 on DBT and 278 on DM were rated as BI-RADS 4a and above. Of the 486 ratings for benign lesions, 220 on DBT and 206 on DM were rated as BI-RADS 4a and above. On average, 17.8% (65 of 366) more malignant lesions and 2.9% (14 of 486) more benign lesions would be recommended for biopsy using DBT. The inter-radiologist variability was reduced significantly. With DBT alone, the BI-RADS assessment of breast lesions and inter-radiologist reliability were significantly improved compared to DM.

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