Mirai-MRI: Validation of AI Models for Breast Cancer Risk
Start Date
11/3/2025
Completion Date
1/31/2027
Summary
This is a multi-center, single arm trial to evaluate the cancer detection rate of supplemental screening magnetic resonance imaging (MRI) in participants who are high-risk by Mirai-MRI assessment. Mirai is an accurate cancer risk model based on full-resolution mammograms.
Detailed Description
PRIMARY OBJECTIVE: I. To estimate the cancer detection rate (CDR) of supplemental screening breast MRI in participants who are high-risk by the Mirai model SECONDARY OBJECTIVES: I. To estimate the CDR of supplemental screening breast MRI in participants with high Mirai risk and low (\<20%) lifetime Tyrer-Cuzick (TC) risk. II. To compare the CDR of supplemental screening breast MRI in participants with high Mirai risk and high (≥ 20%) lifetime TC risk versus CDR in participants with high Mirai risk and low (\<20%) lifetime TC risk. III. To estimate the positive predictive value (PPV)1, PPV2, and PPV3 of supplemental MRI screening in participants with high Mirai risk. IV. To estimate the false positive rate (1 - specificity) of supplemental screening MRI in participants with high Mirai risk. V. To evaluate the tumor size, stage, grade, histological and molecular subtypes, Ki-67 percentage, and lymph node involvement of cancers detected on supplemental screening MRI in Mirai high risk participants. VI. To evaluate the association between race/ethnicity, menopausal status, hormonal status, breast density, family history of cancer, and CDR in Mirai high-risk participants.
Eligibility Criteria
Age Range: 40 years to 89 years
Interventions
Magnetic resonance imaging (MRI)
Artificial Intelligence (AI)
Conditions
Locations
University of California, San Diego
San Diego, California 92093
United States
University of California, San Francisco
San Francisco, California 94143
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts 01655
United States