RecruitingNot ApplicableNCT07121972

Mirai-MRI: Validation of AI Models for Breast Cancer Risk

Mirai-MRI: Multi-site Prospective Validation of AI Models for Breast Cancer Risk

Sponsor

University of California, San Francisco

Enrollment

400 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

Cancer Risk Breast Cancer Risk

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.

Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 89 Years

Inclusion Criteria4

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.
Screening mammogram assessed as high-risk by Mirai (top 3 percentile of 2-year risk).
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) images.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria15

Screening mammogram that is assessed as BI-RADS 0 for technical recall.
Contraindications for MRI:
Metallic foreign body in the eye.
MRI unsafe implants and/or medical devices.
Adverse reaction to a (gadolinium-based) contrast agent in the past.
Pregnant women.
Claustrophobia.
Exceeds site specific size and/or weight limit for MRI.
If the participant meets site-specific criteria for screening estimated glomerular filtration rate (eGFR) prior to MRI, participants with severely impaired renal function (GFR \< 30 mL/min) will be excluded. According to University of California, San Francisco's policy for MRI with contrast (gadolinium-containing), serum creatinine with calculation of eGFR should be obtained within 6 weeks of the MRI study for participants with any of the following risk factors:
History of "kidney disease" as an adult, including renal tumor or transplant.
Diabetes treated with insulin or other prescribed medications.
Hypertension (high blood pressure) requiring medication.
Multiple myeloma.
Solid organ transplant.
History of severe hepatic disease/liver transplant/pending liver transplant.