Popis: |
The purpose of this study was to test for superiority of wide-angle digital breast tomosynthesis plus synthetic mammography (Insight 2D) in comparison to full-field digital mammography (FFDM).In this study, twenty readers interpreted 350 screening and diagnostic cases of wide-angle digital breast tomosynthesis (DBT) plus Insight 2D and FFDM in two separate reading sessions separated by at least a 6-week washout period. Breast-level estimates of the area under the curve and sensitivity along with subject-level recall rate were measured and compared between wide-angle DBT plus Insight 2D and FFDM. The same measures were also assessed for dense breasts. A hierarchical analysis plan was used to control the study's type I error rate at 0.05.The mean breast-level area under the curve for distinguishing breasts with cancer from non-cancer breasts was 0.893 with DBT plus Insight 2D versus 0.837 with FFDM, showing superiority of DBT plus Insight 2D (p0.001). Breast-level sensitivity was significantly superior for DBT plus Insight 2D in comparison to FFDM (0.852 vs. 0.805, p = 0.043). Subject-level recall rate for DBT plus Insight 2D was significantly lower in comparison to FFDM (0.344 vs. 0.473, p0.001). For dense breasts, the readers' accuracy with DBT plus Insight 2D was superior to their accuracy with FFDM (0.875 vs. 0.830, p = 0.026), and their recall rate was significantly lower for DBT plus Insight 2D in comparison to FFDM (0.338 vs. 0.441, p = 0.003).Reader performance with wide-angle DBT plus Insight 2D is superior to that with FFDM, showing significantly higher breast-level accuracy and sensitivity and significantly lower recall rates. |