Diagnostic performance of digital breast tomosynthesis and full-field digital mammography with new reconstruction and new processing for dose reduction.

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The main barrier to adoption of digital breast tomosynthesis (DBT) plus full-field digital mammography (FFDM) is radiation exposure dose. The purpose of this study was to evaluate the diagnostic performance of DBT plus FFDM, both with newly developed technology (nd), at a dose comparable to that of the conventional FFDM alone. Nine hundred and thirteen participants were recruited from May 2014 to January 2016 consecutively. For each subject, the exposure setting for DBT(nd)+FFDM(nd) was also used for the conventional FFDM alone. Retrospective reader studies were performed: DBT(nd)+FFDM(nd) (142 cases, including 42 cancer cases) and conventional FFDM (258 cases, including 87 cancer cases). Eight radiologists provided Japanese categorizations and probability of malignancy independently. Diagnostic performance was assessed by comparing sensitivity, specificity, and area under the receiver operating characteristic curve (AUC). Two-sided P values were calculated. DBT(nd)+FFDM(nd) showed sensitivity and AUC significantly increased over the conventional FFDM (85.4 vs. 80.3%, P=0.015 and 90.9 vs. 88.3%, P=0.049) and specificity did not significantly increase (89.6 vs. 88.4%, P=0.52). The mean glandular dose (MGD) difference of DBT(nd)+FFDM(nd) and conventional FFDM was not significant (difference -0.11mGy, P=0.08). In this study population, DBT plus FFDM, both with newly developed technology, provided diagnostic performance improved over the conventional FFDM alone, even at comparable MGD.