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

NCT05968157 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-07

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Breast MRI

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

DEVICE

MIRAI

Artificial intelligence software

Sponsors & Collaborators

Principal Investigators

  • Mohammed Salman Shazeeb, PhD · UMass Chan Medical School

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-04
Primary Completion
2026-06-30
Completion
2027-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05968157 on ClinicalTrials.gov