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

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.