Mirai-MRI: Multi-site Prospective Validation of AI Models for Breast Cancer Risk
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.
Arms & interventions
- ProcedureMagnetic resonance imaging (MRI)
Undergo Magnetic resonance (MR) imaging
- DeviceArtificial Intelligence (AI)
AI applied to MRI images
Outcome measures
Primary
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
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
Correlation between hormonal status and CDR
Time frame: Up to 1 year
Correlation between breast density and CDR
Time frame: Up to 1 year
Correlation between family history of cancer and CDR
Time frame: Up to 1 year
Eligibility criteria
Study locations (4)
University of California, San Diego
San Diego, California, 92093
University of California, San Francisco
San Francisco, California, 94143
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655