RecruitingNot ApplicableNCT07121972

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

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


Sponsor

University of California, San Francisco

Enrollment

400 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 40 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an AI tool called Mirai-MRI that uses MRI scans to predict a woman's risk of developing breast cancer in the future, without needing additional imaging. **You may be eligible if...** - You were assigned female at birth and are between 40 and 89 years old - You recently had a routine screening mammogram that came back normal (BI-RADS 1 or 2) - You are asymptomatic (no current breast symptoms or concerns) **You may NOT be eligible if...** - Your mammogram showed findings that needed further follow-up beyond a normal result - You have current breast symptoms Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMagnetic resonance imaging (MRI)

Undergo Magnetic resonance (MR) imaging

DEVICEArtificial Intelligence (AI)

AI applied to MRI images


Locations(4)

University of California, San Diego

San Diego, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT07121972


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