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

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Francisco
Study ID
NCT07121972
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer Risk
  • Cancer Risk

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • Magnetic resonance imaging (MRI) — PROCEDURE
    Undergo Magnetic resonance (MR) imaging
  • Artificial Intelligence (AI) — DEVICE
    AI applied to MRI images

Study Details

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.

Key Dates

Start date
Nov 3, 2025
Status verified
Nov 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Supplemental MRI
    Participants identified as Mirai high-risk on a negative/benign screening mammogram will receive a supplemental MRI within 12 months of receiving a screening mammogram. Breast cancer risk following the Tyrer-Cuzick risk model will be assessed for comparison.

Primary Outcome Measure

Cancer detection rate (CDR) [ Time Frame: Up to 1 year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92093-
University of California, San FranciscoSan FranciscoCalifornia94143
Tiffany Tran
[email protected]
[email protected]
Maggie Chung, MD (PRINCIPAL_INVESTIGATOR)
Adam Yala, PhD (PRINCIPAL_INVESTIGATOR)
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
University of Massachusetts Memorial Medical CenterWorcesterMassachusetts01655-

Find similar trials in San Diego, CA

By research site
University of California, San Diego· San Diego, CAUniversity of California, San Francisco· San Francisco, CAUniversity of Chicago Comprehensive Cancer Center· Chicago, ILUniversity of Massachusetts Memorial Medical Center· Worcester, MA

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