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NCT Number: NCT05968157

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location status: Recruiting

Location contact

Mohammed Shazeeb, PhD

CONTACT

[email protected]

508-856-4255

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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

Treatment and study plan

Breast MRI

Diagnostic Test

Supplemental MRI (in addition to standard of care MRI).

MIRAI

Device

Artificial intelligence software

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Schiller, MPH

CONTACT

[email protected]

7744417731

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Breast Cancer Research Foundation
  • Massachusetts Institute of Technology

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 1, 2023
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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