AI (Mirai)-guided supplemental MRI to find breast cancer in women at high Mirai risk

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

This will test whether adding a screening breast MRI finds more cancers in women whose mammograms are flagged as high risk by the Mirai AI model.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 40 Years to 89 Years
• Sex: Female
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 4 sites (San Diego, California and 3 other locations)
• Trial ID: NCT07121972 on ClinicalTrials.gov

What this trial studies

This single-arm, multi-center study enrolls asymptomatic people assigned female at birth aged 40–89 whose routine mammograms are scored in the top 3% of 2-year risk by the Mirai AI model and are BI-RADS 1 or 2. Enrolled participants receive supplemental screening breast MRI and outcomes measured include cancer detection rate (CDR), positive predictive values (PPV1/2/3), and the false positive rate. The trial will compare CDRs between participants with high Mirai risk who have low versus high Tyrer-Cuzick lifetime risk and will characterize tumor features and associations with demographics, breast density, and hormonal status. Key exclusions include technical mammogram recalls, MRI contraindications (including MRI-unsafe implants, metallic ocular foreign bodies, prior adverse gadolinium reactions), and pregnancy.

Who should consider this trial

Good fit: Asymptomatic people assigned female at birth aged 40–89 with screening mammograms rated BI-RADS 1 or 2 and whose Mirai risk falls in the top 3% for 2-year risk are ideal candidates.

Not a fit: People with MRI contraindications, technical-recall mammograms, pregnancy, or those not in the high Mirai risk group are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, adding MRI for Mirai-identified high-risk women could detect cancers earlier and allow earlier treatment.

How similar studies have performed: Supplemental screening MRI has previously detected additional cancers in other high-risk groups, but using the Mirai AI model to select MRI candidates is a newer approach with limited prior validation.

Eligibility criteria

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.

Where this trial is running

San Diego, California and 3 other locations

• University of California, San Diego — San Diego, California, United States (Not_yet_recruiting)
• University of California, San Francisco — San Francisco, California, United States (Recruiting)
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States (Not_yet_recruiting)
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Maggie Chung, MD — University of California, San Francisco
• Study coordinator: Tiffany Tran

Conditions Cancer Risk; Breast Cancer Risk; Screening; BI-RADS