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

January 6, 2026 updated by: Mohammad Salman Shazeeb, University of Massachusetts, Worcester

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

    1. These patients will be invited to receive a supplemental MRI examination currently considered the most sensitive test for breast cancer detection.
    2. 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:

    1. A report of a routine screening mammogram or diagnostic mammogram, and availability of the DICOM images from that report with the PACS system.
    2. Reports of all follow up screening and diagnostic studies documented on PACS.
    3. 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Risk Participants--MIRAI
Patients who are deemed high risk on standard breast screening mammogram by the MIRAI model
Diagnostic test: Breast MRI
Supplemental MRI (in addition to standard of care MRI).
Device: MIRAI
Artificial intelligence software
Active Comparator: High Risk Participants--non-MIRAI
Patients who are deemed high risk by Tyrer-Cuzick model but not MIRAI
Diagnostic test: Breast MRI
Supplemental MRI (in addition to standard of care MRI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDR Mirai Assessment versus CDR Traditional High Risk Screening
Time Frame: 1.5 years (duration of patient recruitment and outcome data collection)
Cancer detection rate from breast MRI following Mirai assessment of high risk on a screening mammogram performed less than 1 year ago and compared with established CDR in traditional high risk screening.
1.5 years (duration of patient recruitment and outcome data collection)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer development within study population versus general population of average risk women
Time Frame: 1.5 years (duration of patient recruitment and outcome data collection)
On subsequent follow-up with standard of care, assessment of what percentage of the study population develops breast cancer as compared to the general population of women at average risk of breast cancer.
1.5 years (duration of patient recruitment and outcome data collection)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

Massachusetts Institute of Technology
Breast Cancer Research Foundation

Investigators

  • Principal Investigator: Mohammed Salman Shazeeb, PhD, UMass Chan Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY000000485
  • MIT_s5822 (Other Grant/Funding Number: Massachusetts Institute of Technology Subaward)
  • SPEC-22-015 (Other Grant/Funding Number: Breast Cancer Research Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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