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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting
• University of Massachusetts Memorial Medical Center
  Worcester, Massachusetts, United States Recruiting
• University of California, San Diego
  San Diego, California, United States Not yet recruiting
• University of Chicago Comprehensive Cancer Center
  Chicago, Illinois, United States Not yet recruiting

Study contacts

• Principal investigator: Maggie Chung, MD — University of California, San Francisco
• Study coordinator: Tiffany Tran
• Email: tiffany.tran3@ucsf.edu
• Phone: 877-827-3222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.