Comparison of New and Established Full-Field Digital Mammography Systems in Diagnostic Performance

OBJECTIVE To compare the diagnostic performance of new and established full-field digital mammography (FFDM) systems. MATERIALS AND METHODS During a 15-month period, 1038 asymptomatic women who visited for mammography were prospectively included from two institutions. For women with routine two-view mammograms from established FFDM systems, bilateral mediolateral oblique (MLO) mammograms were repeated using the new FFDM system. One of the four reviewers evaluated two-sets of bilateral MLO mammograms at 4-week intervals by using a five-point score for the probability of malignancy according to a Breast Imaging Reporting and Data System. The lesion type and breast density were determined by the consensus of two readers at each institution. The dichotomized mammographic results correlated with a final pathologic outcome and follow-up data. Receiver operating characteristic (ROC) curves, sensitivity, and specificity were compared in general and according to the lesion type and breast density. RESULTS Of the 1038 cases, 193 (18.6%) had cancer. The areas under the ROC curve (AUC), sensitivity, and specificity of the established system were 0.815, 65.3%, and 90.2%, respectively. Those of the new system were 0.839, 68.4%, and 91.7%, respectively. There were no significant differences in the AUCs, sensitivities or the specificities in general between new and established systems (Ps = 0.194, 0.590, 0.322, respectively). We found no significant difference in these parameters according to lesion type or breast density. CONCLUSION The new FFDM system has a comparable diagnostic performance with established systems.