Health TrialsbyHealthPanel

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

ConditionsCancer RiskBreast Cancer Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-89
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Screening mammogram that is assessed as BI-RADS 0 for technical recall.

Metallic foreign body in the eye.

MRI unsafe implants and/or medical devices.

Adverse reaction to a (gadolinium-based) contrast agent in the past.

Trial design

Design model

Single group

Treatments tested in this trial

  • Magnetic resonance imaging (MRI)

    Procedure/Surgery

    Undergo Magnetic resonance (MR) imaging

  • Artificial Intelligence (AI)

    Device

    AI applied to MRI images

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Supplemental MRIExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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 outcomes

1

CDR of participants designated as low risk using the Tyrer-Cuzick (TC) criteria

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.

Time frame
Up to 1 year
2

Comparison of CDR in low and high TC risk groups

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.

Time frame
Up to 1 year
3

Positive predictive value of supplemental MRI screening and BI-RADS Score (PPV1)

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.

Time frame
Up to 1 year
4

Positive predictive value of supplemental MRI screening recommending histological or surgical follow-up (PPV2)

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.

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Breast Cancer Research Foundation

Collaborator

Source ClinicalTrials.gov
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