Prospective Evaluation of AI Risk Stratification for Triaging Expedited Screening Mammogram Interpretation
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PURPOSE
To prospectively evaluate the feasibility and performance of expedited screening mammogram interpretation for women identified as high-risk by a deep learning risk model.
METHODS AND MATERIALS
This HIPAA-compliant, IRB-approved prospective controlled study was conducted at an urban safety-net facility. The Mirai breast cancer risk model was retrospectively calibrated on 114,229 local mammograms (2006–2023) to identify the top 10% of 1-year breast cancer risk scores. During the prospective study (12/2024-6/2025), Mirai 1-year risk scores were generated in real time. On enrollment days, high-risk women were approached for consent and offered immediate interpretation of their screening exam. Patients assessed as BI-RADS 0 were offered same-day diagnostic evaluation when feasible. Outcomes included feasibility of immediate interpretation, time to screening result (Ts), diagnostic evaluation (Td), and biopsy (Tb), as well as cancer detection rate (CDR). Comparisons were made with high-risk controls on non-enrollment days.
RESULTS
Among 4,145 screening mammograms, Mirai flagged 525 (12.7%) as high-risk; 973 (23.5%) were performed on enrollment days with 115 (11.8%) flagged as high-risk. Of 100 women who consented, 94% received immediate reads. Thirty-one were assessed as BI-RADS 0; 30 underwent diagnostic imaging (26 same day). Thirteen biopsies yielded 6 malignant (4 invasive, 2 DCIS), 2 high-risk, and 5 benign lesions. The CDR in high-risk expedited women was 60/1,000 (95% CI, 22.3–126.0) compared with 2.3/1,000 (95% CI, 0.3–8.4) in non-high-risk women (odds ratio 27.1; p<0.001). Median Ts, Td, and Tb were significantly shorter in expedited patients versus high-risk controls (13.0 min vs 191.9 min; 1.3 hrs vs 852.8 hrs; 20.1 vs 59.0 days; all p<0.001). For screen-detected cancers, expedited interpretation reduced mean Ts, Td, and Tb by 99.1%, 99.1%, and 87.2%, respectively.
CONCLUSION
Integrating an AI risk model into mammography workflow is feasible and enables same-day evaluation for high-risk women. This approach markedly shortens time to diagnostic imaging and biopsy to provide timely breast cancer care.
