Prospective Evaluation of AI Risk Stratification for Triaging Expedited Screening Mammogram Interpretation

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.

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 validated on 114,229 local mammograms (2006–2023) to identify the top 10% of 1-year breast cancer risk threshold. 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 consented and offered immediate screening mammogram interpretation. 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.

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, 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 vs. 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.

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 for timely breast cancer care. Competing Interest Statement Maggie Chung and Adam Yala are stockholders of Voio Inc. Funding Statement Adam Yala is supported by the E.P. Evans Foundation, Breast Cancer Research Foundation, and NIH R37 awards. Maggie Chung is supported by the Radiological Society of North America Research Scholar Grant and NIH R37 award. These funders did not directly influence or partake in this study. Eric Davis received a T32 grant, which supported his involvement in this work. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Ethics Committee/Institutional Review Board of the University of California San Francisco gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes Corrected name of coauthor Rita Freimanis. Data Availability All data produced in the present study are available upon reasonable request to the authors.