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

NCT07121972 | Recruiting FDA Device

• 2 other identifiers: 25756NCI-2025-06040
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Screening; BI-RADS

Outcome Measures

Primary Outcomes (1)

• Cancer detection rate (CDR)

  The CDR is defined as the number of breast cancers identified per 1,000 magnetic resonance imaging (MRI) screening examinations performed 1 year following supplemental screening MRI.

  Up to 1 year

Secondary Outcomes (15)

• CDR of participants designated as low risk using the Tyrer-Cuzick (TC) criteria

  Up to 1 year

• Comparison of CDR in low and high TC risk groups

  Up to 1 year

• Positive predictive value of supplemental MRI screening and BI-RADS Score (PPV1)

  Up to 1 year

• Positive predictive value of supplemental MRI screening recommending histological or surgical follow-up (PPV2)

  Up to 1 year

• Positive predictive value of biopsies resulting in histological diagnosis (PPV3)

  Up to 1 year

Study Arms (1)

Supplemental MRI

EXPERIMENTAL

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.

Procedure: Magnetic resonance imaging (MRI); Device: Artificial Intelligence (AI)

Interventions

Magnetic resonance imaging (MRI) PROCEDURE

Undergo Magnetic resonance (MR) imaging

Also known as: MRI, MRI Scan

Supplemental MRI

Artificial Intelligence (AI) DEVICE

AI applied to MRI images

Also known as: AI Models, AI Algorithm

Supplemental MRI

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Screening mammogram that is assessed as BI-RADS 0 for technical recall.
• Contraindications for MRI:
• Metallic foreign body in the eye.
• MRI unsafe implants and/or medical devices.
• Adverse reaction to a (gadolinium-based) contrast agent in the past.
• Pregnant women.
• Claustrophobia.
• Exceeds site specific size and/or weight limit for MRI.
• If the participant meets site-specific criteria for screening estimated glomerular filtration rate (eGFR) prior to MRI, participants with severely impaired renal function (GFR \< 30 mL/min) will be excluded. According to University of California, San Francisco's policy for MRI with contrast (gadolinium-containing), serum creatinine with calculation of eGFR should be obtained within 6 weeks of the MRI study for participants with any of the following risk factors:
• History of "kidney disease" as an adult, including renal tumor or transplant.
• Diabetes treated with insulin or other prescribed medications.
• Hypertension (high blood pressure) requiring medication.
• Multiple myeloma.
• Solid organ transplant.
• History of severe hepatic disease/liver transplant/pending liver transplant.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (4)

University of California, San Diego

San Diego, California, 92093, United States

NOT YET RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Maggie Chung, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Tran

CONTACT

877-827-3222; tiffany.tran3@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 14, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (4)