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New treatment option for Cancer Risk
Official title Mirai-MRI: Validation of AI Models for Breast Cancer Risk
ClinicalTrials.gov ID: NCT07121972
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 89, women only. Healthy volunteers may be eligible.
You may be able to join if
- All asymptomatic participants assigned female at birth, ages 40-89 years old with screening mammography assessed as Breast Imaging Reporting and Data...
- Screening mammogram assessed as high-risk by Mirai (top 3 percentile of 2-year risk).
- Availability of a routine screening mammogram report, along with a subsequent diagnostic mammogram report if applicable, and access to the...
- Ability to understand and the willingness to sign a written informed consent document.
You likely can't join if
- Screening mammogram that is assessed as BI-RADS 0 for technical recall.
- Contraindications for MRI:
- Metallic foreign body in the eye.
- MRI unsafe implants and/or medical devices.
- Adverse reaction to a (gadolinium-based) contrast agent in the past.
- Pregnant women.
See the full eligibility criteria
- 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...
- Screening mammogram assessed as high-risk by Mirai (top 3 percentile of 2-year risk).
- 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.
- Ability to understand and the willingness to sign a written informed consent document.
- Screening mammogram that is assessed as BI-RADS 0 for technical recall.
- Contraindications for MRI:
- Metallic foreign body in the eye.
- MRI unsafe implants and/or medical devices.
- Adverse reaction to a (gadolinium-based) contrast agent in the past.
- Pregnant women.
- Claustrophobia.
- Exceeds site specific size and/or weight limit for MRI.
- 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...
- History of "kidney disease" as an adult, including renal tumor or transplant.
- Diabetes treated with insulin or other prescribed medications.
- Hypertension (high blood pressure) requiring medication.
- Multiple myeloma.
- Solid organ transplant.
- History of severe hepatic disease/liver transplant/pending liver transplant.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- San Francisco, California, United States
- Chicago, Illinois, United States
- Worcester, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 89 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; San Francisco, California, United States; Chicago, Illinois, United States; Worcester, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.