Mirai-MRI: Validation of AI Models for Breast Cancer Risk
Sponsored by University of California, San Francisco
About this study
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.
PRIMARY OBJECTIVE: I. 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. II. 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. III. To estimate the positive predictive value (PPV)1, PPV2, and PPV3 of supplemental MRI screening in participants with high Mirai risk. IV. To estimate the false positive rate (1 - specificity) of supplemental screening MRI in participants with high Mirai…
Where this study is enrolling (2)
- I'm interested
University of California, San Francisco
San Francisco, California
- I'm interested
University of Chicago Comprehensive Cancer Center
Chicago, Illinois
Who can participate
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.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.