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 groupSponsors and collaborators
University of California, San Francisco
Lead sponsor
Breast Cancer Research Foundation
Collaborator
Source ClinicalTrials.gov