Clinical performance of tomosynthesis in one view at the same total dose as standard screen-film mammography is not inferior to digital mammography in two views.

• Digital breast tomosynthesis is becoming adopted as an adjunct to mammography (MX) • DBT (MLO) +MX (CC) is superior to MX (CC+MLO) in lesion detection (overall and benign lesions) • DBT (MLO) +MX (CC) is non-inferior to MX (CC+MLO) in cancer detection • DBT (MLO) +MX (CC) is superior to MX (CC+MLO) in lesion characterization (overall and benign lesions) • DBT (MLO) +MX (CC) is non-inferior to MX (CC+MLO) in characterization of malignant lesions.

In this enriched study population, the combination of single-view MLO tomosynthesis plus single-view CC mammography was non-inferior to that of standard two-view digital mammography in terms of ROC curve area, sensitivity and specificity.