DIGITAL BREAST TOMOSYNTHESIS VERSUS DIGITAL MAMMOGRAPHY: A CLINICAL PERFORMANCE STUDY

Abstract: Purpose: To compare the diagnostic accuracy of two-dimensional (2D) full-field digital mammography with that of two-view (mediolateral and craniocaudal) and single-view (mediolateral oblique) tomosynthesis in an observer study involving two institutions. Materials and Methods: Ethical committee approval was obtained. All participating women gave informed consent. Two hundred twenty women (mean age, 56.3; range, 40-80 years) with breast density of 2-4 according to American College of Radiology criteria were recruited between November 2008 and September 2009 and underwent standard treatment plus tomosynthesis with a prototype photon-counting machine. After exclusion criteria were met, this resulted in a final test set of 130 women. Ten accredited readers classified the 130 cases (40 cancers, 24 benign lesions, and 66 normal images) using 2D mammography and two-view tomosynthesis. Another 10 readers reviewed the same cases using 2D mammography but single-view tomosynthesis. The multireader, multicase receiver operating characteristic (ROC) method was applied. The significance of the observed difference in accuracy between 2D mammography and tomosynthesis was calculated. Results: For diagnostic accuracy, 2D mammography performed significantly worse than two-view tomosynthesis (average area under ROC curve [AUC] = 0.772 for 2D, AUC = 0.851 for tomosynthesis, P = .021). Significant differences were found for both masses and microcalcification (P = .037 and .049). The difference in AUC between the two modalities of 20.110 was significant (P = .03) only for the five readers with the least experience (