Mirai-MRI: Validation of AI Models for Breast Cancer Risk
Recruiting now · Not applicable
Conditions studied: Cancer Risk, Breast Cancer Risk
In brief
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.
Key facts
- Study ID
- NCT07121972
- Run by
- University of California, San Francisco
- People needed
- 400
- Starts
- 2025-11-03
- Expected to finish
- 2027-01-31
- Last updated by the study team
- 2025-11-06
Who can join
Age: 40 and older, up to 89. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of California, San Francisco — San Francisco, California, United States (enrolling)
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States (enrolling)
- University of California, San Diego — San Diego, California, United States
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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