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Mirai-MRI: Validation of AI Models for Breast Cancer Risk

Mirai-MRI: Multi-site Prospective Validation of AI Models for Breast Cancer Risk

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 89 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This is a multi-center, single arm trial to evaluate the cancer detection rate of supplemental screening magnetic resonance imaging (MRI) in participants who are high-risk by Mirai-MRI assessment."
  • "To estimate the cancer detection rate (CDR) of supplemental screening breast MRI in participants who are high-risk by the Mirai model SECONDARY OBJECTIVES: I."
  • "To estimate the CDR of supplemental screening breast MRI in participants with high Mirai risk and low (\<20%) lifetime Tyrer-Cuzick (TC) risk."
  • "To compare the CDR of supplemental screening breast MRI in participants with high Mirai risk and high (≥ 20%) lifetime TC risk versus CDR in participants with high Mirai risk and low (\<20%) lifetime TC risk."
  • "To estimate the positive predictive value (PPV)1, PPV2, and PPV3 of supplemental MRI screening in participants with high Mirai risk."
  • "To estimate the false positive rate (1 - specificity) of supplemental screening MRI in participants with high Mirai risk."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how often extra breast MRI scans find cancer in people whose mammograms show high risk using Mirai, an AI tool. It is for people assigned female at birth, ages 40–89, who have no symptoms and whose mammogram results show no signs of cancer.

This is a multi-center, single arm trial to evaluate the cancer detection rate of supplemental screening magnetic resonance imaging (MRI) in participants who are high-risk by Mirai-MRI assessment. Mirai is an accurate cancer risk model based on full-resolution mammograms.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You were assigned female at birth, are ages 40–89, and have no symptoms.
  • Your screening mammogram is BI-RADS 1 or 2, meaning normal or showing only non-cancer changes. If more tests were needed at first, your follow-up mammogram must have one of these results.
  • Mirai places your chance of breast cancer in the next 2 years in the highest 3% of scores.
  • Your mammogram reports and digital images are available, including follow-up images and reports if needed.
  • You can understand the study and are willing to sign a consent form.

Who can't join

  • Your screening mammogram needs to be repeated because of a technical problem.
  • You have metal in your eye or an implant or medical device that is unsafe for MRI.
  • You have had a bad reaction to gadolinium, the dye used for MRI.
  • You are pregnant.
  • You have claustrophobia, a fear of enclosed spaces.
  • You exceed the MRI center’s size or weight limit.
  • If your study center requires a kidney test before MRI, the test shows severely reduced kidney function (GFR below 30 mL/min).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. All asymptomatic participants assigned female at birth, ages 40-89 years old with screening mammography assessed as Breast Imaging Reporting and Data System (BI-RADS) 1, BI-RADS 2, or initial BI-RADS 0 with subsequent diagnostic mammogram assessed as BI-RADS 1 or BI-RADS 2. 2. Screening mammogram assessed as high-risk by Mirai (top 3 percentile of 2-year risk). 3. Availability of a routine screening mammogram report, along with a subsequent diagnostic mammogram report if applicable, and access to the corresponding Digital Imaging and Communications in Medicine (DICOM) images. 4. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Screening mammogram that is assessed as BI-RADS 0 for technical recall. 2. Contraindications for MRI: 1. Metallic foreign body in the eye. 2. MRI unsafe implants and/or medical devices. 3. Adverse reaction to a (gadolinium-based) contrast agent in the past. 4. Pregnant women. 5. Claustrophobia. 6. Exceeds site specific size and/or weight limit for MRI. 3. If the participant meets site-specific criteria for screening estimated glomerular filtration rate (eGFR) prior to MRI, participants with severely impaired renal function (GFR \< 30 mL/min) will be excluded. According to University of California, San Francisco's policy for MRI with contrast (gadolinium-containing), serum creatinine with calculation of eGFR should be obtained within 6 weeks of the MRI study for participants with any of the following risk factors: 1. History of "kidney disease" as an adult, including renal tumor or transplant. 2. Diabetes treated with insulin or other prescribed medications. 3. Hypertension (high blood pressure) requiring medication. 4. Multiple myeloma. 5. Solid organ transplant. 6. History of severe hepatic disease/liver transplant/pending liver transplant.

Study sites (4)

CA

IL

MA