Recall Rate Reduction with Tomosynthesis During Baseline Screening Examinations: An Assessment From a Prospective Trial.

RATIONALE AND OBJECTIVES

Assess results of a prospective, single-site clinical study evaluating digital breast tomosynthesis (DBT) during baseline screening mammography.

MATERIALS AND METHODS

Under an institutional review board-approved Health Insurance Portability and Accountability Act (HIPAA)-compliant protocol, consenting women between ages 34 and 56 years scheduled for their initial and/or baseline screening mammogram underwent both full field digital mammography (FFDM) and DBT. The FFDM and the FFDM plus DBT images were interpreted independently in a reader by mode balanced approach by two of 14 participating radiologists. A woman was recalled for a diagnostic work-up if either radiologist recommended a recall. We report overall recall rates and related diagnostic outcome from the 1080 participants. Proportion of recommended recalls (Breast Imaging Reporting and Data System 0) were compared using a generalized linear mixed model (SAS 9.3) with a significance level of P = .0294.

RESULTS

The fraction of women without breast cancer recommended for recall using FFDM alone and FFDM plus DBT were 412 of 1074 (38.4%) and 274 of 1074 (25.5%), respectively (P < .001). Large inter-reader variability in terms of recall reduction was observed among the 14 readers; however, 11 of 14 readers recalled fewer women using FFDM plus DBT (5 with P < .015). Six cancers (four ductal carcinomas in situ [DCIS] and two invasive ductal carcinomas [IDC]) were detected. One IDC was detected only on DBT and one DCIS cancer was detected only on FFDM, whereas the remaining cancers were detected on both modalities.

CONCLUSIONS

The use of FFDM plus DBT resulted in a significant decrease in recall rates during baseline screening mammography with no reduction in sensitivity.