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
This trial is looking for women aged 40-89 who are at high risk for breast cancer based on a special assessment. Participants will undergo additional MRI screening to help detect cancer early.
Are You a Good Fit for This Trial?
Rules you outKidney diseaseDiabetesHypertensionMultiple myelomaSolid organ transplantSevere liver disease
You may be able to join if
I am assigned female at birth.
I am between 40 and 89 years old.
I have had a screening mammogram that was assessed as BI-RADS 1, 2, or initial BI-RADS 0 followed by BI-RADS 1 or 2.
I am in the top 3 percentile for breast cancer risk according to the Mirai model.
I can provide my screening mammogram report.
I understand and am willing to sign a consent form.
You may not be able to join if
My screening mammogram was assessed as BI-RADS 0 for technical reasons.
I have a metallic foreign body in my eye.
I have MRI unsafe implants or medical devices.
I have had an adverse reaction to a gadolinium-based contrast agent.
I am pregnant.
I suffer from claustrophobia.
I exceed the size or weight limit for the MRI machine.
I have severely impaired kidney function (GFR < 30 mL/min).
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 three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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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