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

Status: Recruiting
Location: See location...
Intervention Type: Device, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Healthy Volunteers: f
View:

• Women who were identified as high risk on the retrospective study (dating from 2017-2023) 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.

Locations
United States
Massachusetts
UMass Medical School
RECRUITING
Worcester
Contact Information
Primary
Sara Schiller, MPH
sara.schiller1@umassmed.edu
7744417731
Time Frame
Start Date: 2024-02-04
Estimated Completion Date: 2027-09
Participants
Target number of participants: 200
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Breast Cancer Research Foundation, Massachusetts Institute of Technology
Leads: University of Massachusetts, Worcester

This content was sourced from clinicaltrials.gov