Status:
RECRUITING
MIRAI-MRI: Comparing Screening MRI for Patients at High Risk for Breast Cancer Identified by Mirai and Tyrer-Cuzick
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
Massachusetts Institute of Technology
Breast Cancer Research Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
NA
Brief Summary
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 mammogr...
Eligibility Criteria
Inclusion
- Women who were identified as high risk on the retrospective study (dating from 2017-2025) using MIRAI will be recruited and consented for the prospective study
- Women over 40 years of age identified as high risk according to traditional guidelines will also be potentially eligible for this study
- Following consent and enrollment in the study, a participant will subsequently receive the following:
- These patients will be invited to receive a supplemental MRI examination currently considered the most sensitive test for breast cancer detection.
- Any positive diagnosis on MRI will be followed by biopsy to confirm 'truth" of diagnosis.
- To be selected, a given record must include the following:
- A report of a routine screening mammogram or diagnostic mammogram, and availability of the DICOM images from that report with the PACS system.
- Reports of all follow up screening and diagnostic studies documented on PACS.
- Some may have interventional procedures (as long as all of these are done at one of Umass sites) and documentation of these biopsy results in the hospitals EHR.
Exclusion
- Under age 40. Women under 40 years are not routinely xrayed with a mammogram.
- Xray breast cancer screening imaging study that has artifacts, corruption, or other image quality degradation.
- Pregnant patients because they do not routinely receive screening mammogram
- Adult male patients with breast cancer
Key Trial Info
Start Date :
February 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05968157
Start Date
February 4 2024
End Date
September 1 2027
Last Update
January 7 2026
Active Locations (1)
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1
UMass Medical School
Worcester, Massachusetts, United States, 01655