Mirai-MRI: Multi-site Prospective Validation of AI Models for Breast Cancer Risk
University of California, San Francisco
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.
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, PPV…
Eligibility
- Age range
- 40–89 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 1. All asymptomatic participants assigned female at birth, ages 40-89 years old with screening mammography assessed as Breast Imaging Reporting and Data System (BI-RADS) 1, BI-RADS 2, or initial BI-RADS 0 with subsequent diagnostic mammogram assessed as BI-RADS 1 or BI-RADS 2. 2. Screening mammogram assessed as high-risk by Mirai (top 3 percentile of 2-year risk). 3. Availability of a routine screening mammogram report, along with a subsequent diagnostic mammogram report if applicable, and access to the corresponding Digital Imaging and Communications in Medicine (DICOM) i…
Interventions
- ProcedureMagnetic resonance imaging (MRI)
Undergo Magnetic resonance (MR) imaging
- DeviceArtificial Intelligence (AI)
AI applied to MRI images
Locations (4)
- University of California, San DiegoSan Diego, California
- University of California, San FranciscoSan Francisco, California
- University of Chicago Comprehensive Cancer CenterChicago, Illinois
- University of Massachusetts Memorial Medical CenterWorcester, Massachusetts