Mirai-MRI: Validation of AI Models for Breast Cancer Risk
Cancer Risk · Breast Cancer Risk
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 40 years - 89 years
- Sex eligible
- Female
- Healthy volunteers
- Accepted
- Participants
- 400 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Supplemental MRI
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.
Procedure: Magnetic resonance imaging (MRI) · Device: Artificial Intelligence (AI)
Magnetic resonance imaging (MRI) PROCEDURE
Undergo Magnetic resonance (MR) imaging
Artificial Intelligence (AI) DEVICE
AI applied to MRI images
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Cancer detection rate (CDR)
Time frame: Up to 1 year
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.
Secondary measures
CDR of participants designated as low risk using the Tyrer-Cuzick (TC) criteria
Time frame: Up to 1 year
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.
Comparison of CDR in low and high TC risk groups
Time frame: Up to 1 year
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.
Positive predictive value of supplemental MRI screening and BI-RADS Score (PPV1)
Time frame: Up to 1 year
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.
Positive predictive value of supplemental MRI screening recommending histological or surgical follow-up (PPV2)
Time frame: Up to 1 year
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.
Positive predictive value of biopsies resulting in histological diagnosis (PPV3)
Time frame: Up to 1 year
PPV3 is the percentage of all known biopsies performed as a result of positive supplemental MRI screening (BI-RADS 4 or 5) that resulted in a tissue diagnosis of cancer within 1 year.
False Positive Rate (FPR)
Time frame: Up to 1 year
A false positive is defined as an imaging result that incorrectly identifies a condition as present. The FPR = (False Positives / Total Tests) × 100 (or 1 - specificity) of results on supplemental screening MRIs in participants with high Mirai risk.
Mean tumor size detected in supplemental imaging
Time frame: Up to 1 year
Mean tumor size in millimeters (mm) with in situ and invasive components separately on supplemental screening MRI in Mirai high risk participants.
Frequency of tumor stage detected in supplemental imaging
Time frame: Up to 1 year
The frequency of tumor stage diagnosed using the supplemental screening MRI in Mirai high risk participants will be reported.
Proportion of participants with Ki-67 expressed biomarker
Time frame: Up to 1 year
Ki-67 is divided according to percentage levels: \< 15% and \> 15%. The proportion of participants with pathologically confirmed Ki-67 by percentage level will be reported.
Proportion of participants with lymph node involvement detected in supplemental imaging
Time frame: Up to 1 year
The proportion of participants with demonstrated lymph node involvement of cancers detected on the supplemental screening MRI in Mirai high risk participants.
Correlation between race/ethnicity and CDR
Time frame: Up to 1 year
The Spearman's correlation coefficient (rs) will be used to measure the strength and direction of association between race/ethnicity and CDR. The Spearman correlation coefficient, rs, results in values from +1 to -1 where a value of +1 indicates a perfect association, and rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association
Correlation between menopausal status and CDR
Time frame: Up to 1 year
The Spearman's correlation coefficient (rs) will be used to measure the strength and direction of association between menopausal status and CDR. The Spearman correlation coefficient, rs, results in values from +1 to -1 where a value of +1 indicates a perfect association, and rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association
Correlation between hormonal status and CDR
Time frame: Up to 1 year
The Spearman's correlation coefficient (rs) will be used to measure the strength and direction of association between hormonal status and CDR. The Spearman correlation coefficient, rs, results in values from +1 to -1 where a value of +1 indicates a perfect association, and rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association.
Correlation between breast density and CDR
Time frame: Up to 1 year
The Pearson correlation coefficient (r) will be used to measure the strength and direction of association between breast density and CDR. The Pearson correlation coefficient (r) can take values from +1 to -1 where a value of +1 indicates a perfect association, a value of 0 indicates no association, and a value of -1 indicates a perfect negative association. The closer r is to 0, the weaker the association.
Correlation between family history of cancer and CDR
Time frame: Up to 1 year
The Spearman's correlation coefficient (rs) will be used to measure the strength and direction of association between history of cancer and CDR. The Spearman correlation coefficient, rs, results in values from +1 to -1 where a value of +1 indicates a perfect association, and rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (4)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
4 locations
University of California, San DiegoSan Diego, California, United StatesNot yet recruiting
University of California, San FranciscoSan Francisco, California, United StatesRecruiting
University of Chicago Comprehensive Cancer CenterChicago, Illinois, United StatesNot yet recruiting
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts, United StatesRecruiting
Study team and timeline
- Lead sponsor
- University of California, San Francisco
- Study start
- Nov 3, 2025 Actual
- Primary completion
- Jan 31, 2027 Estimated
- Study completion
- Jan 31, 2027 Estimated
- First posted
- Aug 14, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Mirai-MRI: Multi-site Prospective Validation of AI Models for Breast Cancer Risk
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026