NCT07121972 Mirai-MRI: Validation of AI Models for Breast Cancer Risk
| NCT ID | NCT07121972 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Cancer Risk |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-11-03 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-11-03 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Maggie Chung, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07121972 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 89 Years, studying Cancer Risk. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07121972 currently recruiting?
Yes, NCT07121972 is actively recruiting participants. Contact the research team at tiffany.tran3@ucsf.edu for enrollment information.
Where is the NCT07121972 trial being conducted?
This trial is being conducted at San Diego, United States, San Francisco, United States, Chicago, United States, Worcester, United States.
Who is sponsoring the NCT07121972 clinical trial?
NCT07121972 is sponsored by University of California, San Francisco. The principal investigator is Maggie Chung, MD at University of California, San Francisco. The trial plans to enroll 400 participants.
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