Mirai-MRI: Validation of AI Models for Breast Cancer Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-89
SponsorUniversity of California, San Francisco
About this trial
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
Qualifiers
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.
Disqualifiers
Screening mammogram that is assessed as BI-RADS 0 for technical recall.
Metallic foreign body in the eye.
MRI unsafe implants and/or medical devices.
Adverse reaction to a (gadolinium-based) contrast agent in the past.
Trial design
Treatments tested in this trial
- Magnetic resonance imaging (MRI)
- Artificial Intelligence (AI)
Treatment groups
400 Participants
are divided into 1 treatment groupLocations
4University of California, San Diego92093, San DiegoCalifornia, United States
University of California, San Francisco94143, San FranciscoCalifornia, United States
University of Chicago Comprehensive Cancer Center60637, ChicagoIllinois, United States
University of Massachusetts Memorial Medical Center01655, WorcesterMassachusetts, United States
Sponsors and collaborators
University of California, San Francisco
Lead sponsor
Breast Cancer Research Foundation
Collaborator
Source ClinicalTrials.gov