MIRAI-MRI: Comparing Screening MRI for Patients at High Risk for Breast Cancer Identified by Mirai and Tyrer-Cuzick

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT05968157
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Breast MRI — DIAGNOSTIC_TEST
    Supplemental MRI (in addition to standard of care MRI).
  • MIRAI — DEVICE
    Artificial intelligence software

Study Details

Accurate risk assessment is essential for the success of population screening programs and early detection efforts in breast cancer. Mirai is a new deep learning model based on full resolution mammograms. Mirai is a mammography-based deep learning model designed to predict risk at multiple timepoints, leverage potentially missing risk factor information, and produce predictions that are consistent across mammography machines. Mirai was trained on a large dataset from Massachusetts General Hospital (MGH) in the United States and found to be significantly more accurate than the Tyrer-Cuzick model, a current clinical standard. The primary aim of this study is to prospectively quantify the clinical benefit (i.e. MRI/CEM cancer detection rate) of Mirai-based guidelines and to compare them to the current standard of care. 1. Conduct a prospective study where patients who are identified as high risk by Mirai guidelines are invited to receive supplemental MRI within 12 months. 2. Compare cancer outcomes between patients only identified as high risk by Mirai and patients identified as high risk by existing guidelines The secondary aim is to study the impact of new guidelines by race and ethnicity, to ensure equitable improvements in cancer screening.

Key Dates

Start date
Feb 4, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: High Risk Participants--MIRAI
    Patients who are deemed high risk on standard breast screening mammogram by the MIRAI model
  • Active Comparator: High Risk Participants--non-MIRAI
    Patients who are deemed high risk by Tyrer-Cuzick model but not MIRAI

Primary Outcome Measure

CDR Mirai Assessment versus CDR Traditional High Risk Screening [ Time Frame: 1.5 years (duration of patient recruitment and outcome data collection) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UMass Medical SchoolWorcesterMassachusetts01655
Mohammed Shazeeb, PhD
[email protected]
508-856-4255

Find similar trials in Worcester, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UMass Medical School· Worcester, MA

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