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AI could spot breast cancer risk better than current methods

NCT ID NCT05968157

Diagnosis Sponsor: University of Massachusetts, Worcester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This study is testing whether an artificial intelligence program called Mirai can better identify women at high risk for breast cancer compared to traditional risk models. Researchers will invite 200 women flagged as high-risk by Mirai to receive an additional breast MRI. The goal is to see if the AI-guided approach finds more cancers early, especially across different racial and ethnic groups.

What this could mean

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

Active substance
Artificial intelligence software (Mirai) and breast MRI
What this could lead to
If successful, this could show that AI-based risk assessment is more accurate than current methods, leading to earlier breast cancer detection and more personalized screening.
What could go wrong
This is a relatively small, early-stage study (200 participants) comparing two screening approaches, not a treatment trial. The AI may not prove better in practice, and results may not apply to all populations.

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

145 people

The number who actually took part.

Started

Feb 2024

Finished

Feb 2026

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 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Women who were identified as high risk on the retrospective study (dating from 2017-2025) using MIRAI will be recruited and consented for the prospective study * Women over 40 years of age identified as high risk according to traditional guidelines will also be potentially eligible for this study * Following consent and enrollment in the study, a participant will subsequently receive the following: 1. These patients will be invited to receive a supplemental MRI examination currently considered the most sensitive test for breast cancer detection. 2. Any positive diagnosis on MRI will be followed by biopsy to confirm 'truth" of diagnosis. * To be selected, a given record must include the following: 1. A report of a routine screening mammogram or diagnostic mammogram, and availability of the DICOM images from that report with the PACS system. 2. Reports of all follow up screening and diagnostic studies documented on PACS. 3. Some may have interventional procedures (as long as all of these are done at one of Umass sites) and documentation of these biopsy results in the hospitals EHR. Exclusion Criteria: * Under age 40. Women under 40 years are not routinely xrayed with a mammogram. * Xray breast cancer screening imaging study that has artifacts, corruption, or other image quality degradation. * Pregnant patients because they do not routinely receive screening mammogram * Adult male patients with breast cancer

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • UMass Medical School

    Worcester, Massachusetts, 01655, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.