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MIRAI-MRI: Comparing AI and Traditional Screening for High-Risk Breast Cancer

This study is comparing two ways to identify women at high risk for breast cancer: a new artificial intelligence (AI) software called MIRAI, and the traditional Tyrer-Cuzick model. Researchers want to see if MIRAI, which uses mammograms, is better at finding breast cancer early. If you are a woman over 40 who has been identified as high-risk by either MIRAI or traditional guidelines, you might be able to join. The study will look at how well MIRAI helps find breast cancer compared to traditional screening over about 1.5 years. The study plans to enroll 200 women.

Study design
This interventional study plans to enroll 200 women. It compares two methods for identifying high-risk breast cancer patients.
What's involved
Following consent and enrollment, a participant will undergo a supplemental Breast MRI in addition to standard care. The study will collect outcome data for 1.5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 1.5 years for outcome data collection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05968157

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

Recruiting
NAAges 40+InterventionalScreening
University of Massachusetts, Worcester
~200 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:Breast MRIMIRAI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CDR Mirai Assessment versus CDR Traditional High Risk Screening
Measured over 1.5 years (duration of patient recruitment and outcome data collection)

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Mohammed Salman Shazeeb, PhD · PRINCIPAL_INVESTIGATOR · UMass Chan Medical School

Who to contact

Sara Schiller, MPH
[email protected]
7744417731
Email the study team

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Do you actually qualify for this trial?

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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:
To be selected, a given record must include the following:

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

What this trial measures

  • CDR Mirai Assessment versus CDR Traditional High Risk Screening1.5 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.