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

N/ARecruitingNCT07121972

University of California, San Francisco400 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

400

Conditions

Cancer Risk Breast Cancer Risk

Interventions

Magnetic resonance imaging (MRI)PROCEDURE

Undergo Magnetic resonance (MR) imaging

Artificial Intelligence (AI)DEVICE

AI applied to MRI images

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

University of California, San Diego

San Diego, California, United States

NOT_YET_RECRUITING

University of California, San Francisco

San Francisco, California, United States

RECRUITING

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Cancer detection rate (CDR)

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.

Time frame: Up to 1 year

Secondary Outcomes

CDR of participants designated as low risk using the Tyrer-Cuzick (TC) criteria

Cancer detection rate is defined as the number of breast cancers identified per 1,000 MRI screening examinations performed of supplemental screening breast MRI in participants with high Mirai risk and low (\<20%) lifetime TC risk.

Time frame: Up to 1 year

Comparison of CDR in low and high TC risk groups

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 will be compared using a two-proportion exact test.

Time frame: Up to 1 year

Positive predictive value of supplemental MRI screening and BI-RADS Score (PPV1)

PPV1 is the percentage of all positive supplemental MRI screening in participants with high Mirai risk (Breast Imaging Reporting and Data System (BI-RADS) 3, 4, or 5) for which the participant was found to be positive for cancer within 1 year from the time of MRI.

Time frame: Up to 1 year

Positive predictive value of supplemental MRI screening recommending histological or surgical follow-up (PPV2)

PPV2 is the percentage of all supplemental MRI screenings in participants with high Mirai risk recommended for tissue diagnosis or surgical consultation (BI-RADS 4 and 5) that resulted in a histological diagnosis of cancer within 1 year.

Time frame: Up to 1 year

Central Contacts

Tiffany Tran

CONTACT

877-827-3222 tiffany.tran3@ucsf.edu

Data from ClinicalTrials.gov

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