Recruiting
Mirai-MRI: Validation of AI Models for Breast Cancer Risk
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.
ClinicalTrials.gov IDNCT07121972
PhaseNA
Enrollment400
SponsorUniversity of California, San Francisco
Age40 Years
SexFEMALE
Conditions studied
Cancer Risk, Breast Cancer Risk
About this study
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.
Interventions
- Procedure: Magnetic resonance imaging (MRI) — Undergo Magnetic resonance (MR) imaging
- Device: Artificial Intelligence (AI) — AI applied to MRI images
Primary outcomes
- Cancer detection rate (CDR) (Up to 1 year)
Eligibility information
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) images.
4. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
1. Screening mammogram that is assessed as BI-RADS 0 for technical recall.
2. Contraindications for MRI:
1. Metallic foreign body in the eye.
2. MRI unsafe implants and/or medical devices.
3. Adverse reaction to a (gadolinium-based) contrast agent in the past.
4. Pregnant women.
5. Claustrophobia.
6. Exceeds site specific size and/or weight limit for MRI.
3. 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:
1. History of "kidney disease" as an adult, including renal tumor or transplant.
2. Diabetes treated with insulin or other prescribed medications.
3. Hypertension (high blood pressure) requiring medication.
4. Multiple myeloma.
5. Solid organ transplant.
6. History of severe hepatic disease/liver transplant/pending liver transplant.
Study locations
- University of California, San Diego, San Diego, California 92093 United States
- University of California, San Francisco, San Francisco, California 94143 United States
- University of Chicago Comprehensive Cancer Center, Chicago, Illinois 60637 United States
- University of Massachusetts Memorial Medical Center, Worcester, Massachusetts 01655 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.