Mirai-MRI: Validation of AI Models for Breast Cancer Risk
NCT07121972 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2025-11-06
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.
Conditions
- Cancer Risk
- Breast Cancer Risk
Interventions
- PROCEDURE
-
Magnetic resonance imaging (MRI)
Undergo Magnetic resonance (MR) imaging
- DEVICE
-
Artificial Intelligence (AI)
AI applied to MRI images
Sponsors & Collaborators
-
Breast Cancer Research Foundation
collaborator OTHER -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Maggie Chung, MD · University of California, San Francisco
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Max Age
- 89 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-11-03
- Primary Completion
- 2027-01-31
- Completion
- 2027-01-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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