Diagnostic performance of tomosynthesis and breast ultrasonography in women with dense breasts: a prospective comparison study.

PURPOSE

To compare the diagnostic performances of tomosynthesis and ultrasonography as adjunctives to digital mammography in women with dense breasts.

METHODS

A total of 778 women with dense breasts underwent digital mammography with tomosynthesis and ultrasonography for screening and diagnostic purposes. The findings of tomosynthesis and ultrasonography were evaluated independently. The primary endpoint was overall diagnostic accuracy determined by area under the receiver operating characteristic curve (AUC). Secondary endpoints included sensitivity, specificity, and predictive values.

RESULTS

Of the 778 participants, 698 women (140 breast cancers) were included in the analysis. Based on the AUC findings, the non-inferiority of tomosynthesis to ultrasonography was established in the overall group as well as in all subgroups except for that comprising women with extremely dense breast composition. There were no significant differences in AUC between tomosynthesis and ultrasonography among asymptomatic participants and participants who underwent imaging for screening (0.912 vs. 0.934 [P = 0.403] and 0.987 vs. 0.950 [P = 0.270], respectively). Tomosynthesis exhibited lower sensitivity (91.4 vs. 96.4%; P = 0.039), and higher specificity (83.9 vs. 70.4%; P < 0.001) and positive predictive value (58.7 vs. 45.0%; P < 0.001) than ultrasonography.

CONCLUSIONS

Tomosynthesis exhibits comparable performance to ultrasonography as an adjunct to mammography for diagnosis of breast cancer, except among women with extremely dense breasts.