MIRAI-MRI: Comparing Screening MRI for Patients at High Risk for Breast Cancer Identified by Mirai and Tyrer-Cuzick
Recruiting
N/AInterventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
40 and older
Sex
Female
Study type
Interventional
Purpose
Screening
Participants needed
200 (estimated)
Sponsor
University of Massachusetts, Worcester · Other
Who this trial is looking for
This trial is looking for women at high risk for breast cancer to participate in a study comparing a new screening method using MRI. Participants will receive a supplemental MRI scan to help detect breast cancer earlier.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman over 40 years old.
I have been identified as high risk for breast cancer by the Mirai system.
I have a report of a recent mammogram with available images.
I can provide reports of all my follow-up mammograms and other studies.
You may not be able to join if
I am under 40 years old.
I am currently pregnant.
I am a male.
I have had poor quality mammogram images.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 consisten…
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.
Trial Locations
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Eligibility Criteria
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 eli…
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
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