Mirai-MRI: Validation of AI Models for Breast Cancer Risk

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Cancer Risk; Breast Cancer Risk

Treatments: Device: Artificial Intelligence (AI); Procedure: Magnetic resonance imaging (MRI)

Study type: Interventional

Funder types: Other

Identifiers

NCT07121972

NCI-2025-06040 (Registry Identifier)

25756

Details and patient eligibility

About

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.

Full 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.

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 risk.

V. To evaluate the tumor size, stage, grade, histological and molecular subtypes, Ki-67 percentage, and lymph node involvement of cancers detected on supplemental screening MRI in Mirai high risk participants.

VI. To evaluate the association between race/ethnicity, menopausal status, hormonal status, breast density, family history of cancer, and CDR in Mirai high-risk participants.

Enrollment: 400 estimated patients

Sex: Female

Ages: 40 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Supplemental MRI

Experimental group

Description:

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.

Treatment:

Procedure: Magnetic resonance imaging (MRI)

Device: Artificial Intelligence (AI)