Can Contrast-Enhanced Mammography Improve Positive Predictive Value for Diagnostic Workup of Suspicious Findings? A Single-Arm Prospective Study

Objective: To assess the positive predictive value-3 (PPV3) and negative predictive value (NPV) of contrast-enhanced mammography (CEM) when added to the diagnostic workup of suspicious breast findings.

Methods: This prospective study was IRB approved. We recruited 99 women with abnormal findings on digital breast tomosynthesis (DBT) and/or US to undergo CEM prior to biopsy. Based on final pathology outcomes, PPV3 and NPV were calculated and compared using N-1 chi-squared tests with P-values and 95% CIs.

Results: Final pathologic outcome yielded 56.6% (56/99) benign, 5.1% (5/99) benign with upgrade potential (BWUP), and 38.4% (38/99) malignant lesions. Final pathologic outcomes for the 63 positive CEMs yielded 33.3% (21/63) benign, 6.3% (4/63) BWUP, and 60.3% (38/63) malignant lesions. Adding CEM to the diagnostic workup significantly increased PPV3 from 38.4% (38/99) to 60.3% (38/63) (P <.01; 95% CI, 6.1-36.2). Negative predictive value was 100% (36/36) for CEM, 92.9% (13/14; P = .1; 95% CI, -4.2 to 31.4) for DBT, and 75.9% (22/29; P <.05; 95% CI, 8.8-42.1) for US. The number of unnecessary biopsies could be reduced by 36.4% (from 100% [99/99] to 63.6% [63/99]).

Conclusion: Adding CEM to the diagnostic workup of suspicious breast findings could improve PPV3 to prevent unnecessary biopsies.