Actively Recruiting
Mirai-MRI Multi-site Prospective 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
N/A
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
Researchers are evaluating the cancer detection rate of supplemental screening breast MRI in people identified as high-risk for breast cancer by the Mirai AI model, which analyzes full-resolution mammograms. This multi-center, single arm trial aims to validate Mirai's accuracy and compare MRI results in participants with different lifetime risks based on the Tyrer-Cuzick model. Additional goals include assessing tumor characteristics and exploring how factors like race, menopausal and hormonal status, breast density, and family history relate to cancer detection. Participants who are identified as high-risk by Mirai after a screening mammogram with negative or benign results will undergo a supplemental breast MRI within 12 months. The study will compare cancer detection rates between those with high and low Tyrer-Cuzick lifetime risk scores. The MRI images will be analyzed with AI technology to assist in risk assessment and detection. During the study, participants will have a screening mammogram and supplemental MRI, with image data collected for analysis. Researchers will measure cancer detection rates up to one year, along with positive predictive values, false positive rates, and tumor features such as size, stage, grade, and lymph node involvement. The study also monitors correlations between demographic and clinical factors with detection outcomes. Participation involves signing informed consent and undergoing imaging according to protocol, with safety considerations for MRI eligibility.
CONDITIONS
Brief 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 aged 40 to 89 years
- Asymptomatic with screening mammography assessed as BI-RADS 1, 2, or initial BI-RADS 0 followed by diagnostic mammogram assessed as BI-RADS 1 or 2
- Screening mammogram assessed as high-risk by Mirai (top 3 percentile of 2-year risk)
- Availability of routine screening mammogram report and corresponding DICOM images
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Screening mammogram assessed as BI-RADS 0 for technical recall
- Contraindications to MRI including metallic foreign body in eye, MRI unsafe implants/devices, prior adverse reaction to gadolinium contrast, pregnancy, claustrophobia, or exceeding MRI size/weight limits
- Severely impaired kidney function with GFR below 30 mL/min
- History of kidney disease, insulin-treated diabetes, hypertension requiring medication, multiple myeloma, solid organ transplant, or severe liver disease/transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants identified as high-risk by the Mirai model receive a supplemental breast MRI within 12 months of their screening mammogram to monitor for breast cancer.
1 visit (in-person)
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
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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