NCT07121972

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 40 Years – 89 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Cancer Risk
• Breast Cancer Risk

Interventions

Type	Name	Description
PROCEDURE	Magnetic resonance imaging (MRI)	Undergo Magnetic resonance (MR) imaging
DEVICE	Artificial Intelligence (AI)	AI applied to MRI images

Timeline

• Start date: 2025-11-03
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2025-08-14
• Last updated: 2025-11-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study