Actively Recruiting
Mirai-MRI: Validation of AI Models for Breast Cancer Risk
Led by University of California, San Francisco · Updated on 2025-11-06
400
Participants Needed
4
Research Sites
64 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
B
Breast Cancer Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mirai-MRI: Validation of AI Models for Breast Cancer Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Assigned female at birth and between 40 and 89 years old
- Asymptomatic with screening mammography assessed as BI-RADS 1, 2, or initial 0 followed by diagnostic mammogram assessed as BI-RADS 1 or 2
- High-risk screening mammogram by Mirai model (top 3 percentile of 2-year risk)
- Availability of routine screening mammogram report and corresponding images
- Ability and willingness to provide informed consent
You will not qualify if you...
- Screening mammogram assessed as BI-RADS 0 for technical recall
- Metallic foreign body in the eye
- MRI unsafe implants or medical devices
- Past adverse reaction to gadolinium-based contrast agent
- Pregnant women
- Claustrophobia
- Exceeds site-specific size or weight limit for MRI
- Severely impaired renal function (GFR < 30 mL/min) or related kidney disease history
- Diabetes treated with insulin or prescribed medications
- Hypertension requiring medication
- Multiple myeloma
- Solid organ transplant
- Severe hepatic disease, liver transplant, or pending liver transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of California, San Diego
San Diego, California, United States, 92093
Not Yet Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Not Yet Recruiting
4
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Actively Recruiting
Research Team
T
Tiffany Tran
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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