Mirai-MRI: Validation of AI Models for Breast Cancer Risk
Recruiting
N/AInterventional Study
Cancer RiskBreast Cancer Risk
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 89
Sex
Female
Study type
Interventional
Purpose
Screening
Participants needed
400 (estimated)
Sponsor
University of California, San Francisco · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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…
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.
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