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

Authors: Eun Sook Ko, MD, Boo-Kyung Han, MD, Sun Mi Kim, MD, Eun Young Ko, MD, Mijung Jang, MD, Chae Yeon Lyou, MD, Jung Min Chang, MD, Woo Kyung Moon, MD, and Rock Bum Kim, MD


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.