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AI-Powered MRI could spot breast cancer earlier in High-Risk women

NCT ID NCT07121972

Diagnosis Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether using an artificial intelligence (AI) tool called Mirai to guide MRI screening can help find breast cancers earlier. Researchers will enroll 400 women aged 40-89 who are at high risk according to the AI model. Participants will receive a supplemental MRI scan, and the team will track how many cancers are detected within one year. The goal is to see if AI can better identify who needs extra screening beyond standard mammography.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Magnetic resonance imaging (MRI) and artificial intelligence (AI) algorithm
What this could lead to
If successful, this could show that AI can more accurately identify women who would benefit from MRI screening, potentially catching breast cancers earlier.
What could go wrong
This is a single-arm study without a comparison group, so it cannot prove AI-guided screening is better than standard care. The AI model may not perform as well in real-world settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 89 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer risk Cancer risk

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of California, San Diego

    NOT_YET_RECRUITING

    San Diego, California, 92093, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

    Contact Email: •••••@•••••

  • University of Chicago Comprehensive Cancer Center

    NOT_YET_RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Massachusetts Memorial Medical Center

    RECRUITING

    Worcester, Massachusetts, 01655, United States

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