Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07121972

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cancer Risk Breast Cancer Risk

Age range

40 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego, San Diego, California, United States

Loading trial locations.

About this study

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 can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic Resonance Imaging (MRI)

Procedure

Undergo Magnetic resonance (MR) imaging

Other names: MRI, MRI Scan

Artificial Intelligence (AI)

Device

AI applied to MRI images

Other names: AI Models, AI Algorithm

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tiffany Tran

CONTACT

[email protected]

877-827-3222

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Breast Cancer Research Foundation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2025
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.