Mirai-MRI: Multi-site Prospective Validation of AI Models for Breast Cancer Risk
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 400
- Locations
- 4
- Primary Endpoint
- Cancer detection rate (CDR)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 89 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion 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 diagnostic mammogram assessed as BI-RADS 1 or BI-RADS
- •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.
Exclusion Criteria
- •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 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:
- •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.
Arms & Interventions
Supplemental MRI
Participants identified as Mirai high-risk on a negative/benign screening mammogram will receive a supplemental MRI within 12 months of receiving a screening mammogram. Breast cancer risk following the Tyrer-Cuzick risk model will be assessed for comparison.
Intervention: Magnetic resonance imaging (MRI) (Procedure)
Supplemental MRI
Participants identified as Mirai high-risk on a negative/benign screening mammogram will receive a supplemental MRI within 12 months of receiving a screening mammogram. Breast cancer risk following the Tyrer-Cuzick risk model will be assessed for comparison.
Intervention: Artificial Intelligence (AI) (Device)
Outcomes
Primary Outcomes
Cancer detection rate (CDR)
Time Frame: Up to 1 year
The CDR is defined as the number of breast cancers identified per 1,000 magnetic resonance imaging (MRI) screening examinations performed 1 year following supplemental screening MRI.
Secondary Outcomes
- Comparison of CDR in low and high TC risk groups(Up to 1 year)
- Proportion of participants with lymph node involvement detected in supplemental imaging(Up to 1 year)
- CDR of participants designated as low risk using the Tyrer-Cuzick (TC) criteria(Up to 1 year)
- Positive predictive value of supplemental MRI screening and BI-RADS Score (PPV1)(Up to 1 year)
- Positive predictive value of supplemental MRI screening recommending histological or surgical follow-up (PPV2)(Up to 1 year)
- Positive predictive value of biopsies resulting in histological diagnosis (PPV3)(Up to 1 year)
- False Positive Rate (FPR)(Up to 1 year)
- Mean tumor size detected in supplemental imaging(Up to 1 year)
- Correlation between menopausal status and CDR(Up to 1 year)
- Frequency of tumor stage detected in supplemental imaging(Up to 1 year)
- Proportion of participants with Ki-67 expressed biomarker(Up to 1 year)
- Correlation between race/ethnicity and CDR(Up to 1 year)
- Correlation between hormonal status and CDR(Up to 1 year)
- Correlation between breast density and CDR(Up to 1 year)
- Correlation between family history of cancer and CDR(Up to 1 year)