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

Official title

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

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.

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.

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.

Interventions

• Procedure Magnetic resonance imaging (MRI)
  Undergo Magnetic resonance (MR) imaging
• Device Artificial Intelligence (AI)
  AI applied to MRI images

Primary outcome measures

• Cancer detection rate (CDR) [Time frame: Up to 1 year]

Secondary outcome measures (12)

• CDR of participants designated as low risk using the Tyrer-Cuzick (TC) criteria [Time frame: Up to 1 year]
• Comparison of CDR in low and high TC risk groups [Time frame: Up to 1 year]
• Positive predictive value of supplemental MRI screening and BI-RADS Score (PPV1) [Time frame: Up to 1 year]
• Positive predictive value of supplemental MRI screening recommending histological or surgical follow-up (PPV2) [Time frame: Up to 1 year]
• Positive predictive value of biopsies resulting in histological diagnosis (PPV3) [Time frame: Up to 1 year]
• False Positive Rate (FPR) [Time frame: Up to 1 year]
• Mean tumor size detected in supplemental imaging [Time frame: Up to 1 year]
• Frequency of tumor stage detected in supplemental imaging [Time frame: Up to 1 year]
• Proportion of participants with Ki-67 expressed biomarker [Time frame: Up to 1 year]
• Proportion of participants with lymph node involvement detected in supplemental imaging [Time frame: Up to 1 year]
• Correlation between race/ethnicity and CDR [Time frame: Up to 1 year]
• Correlation between menopausal status and CDR [Time frame: Up to 1 year]

Eligibility criteria

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 2.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Screening

Study locations

United States · 4 centers

• University of California, San Diego — San Diego
• University of California, San Francisco — San Francisco
• University of Chicago Comprehensive Cancer Center — Chicago
• University of Massachusetts Memorial Medical Center — Worcester

Identifiers

NCT: NCT07121972 · 25756 · NCI-2025-06040

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗