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AI vs. radiologist: 400,000 women join landmark breast cancer screening trial

NCT ID NCT06934239

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 large trial compares standard mammogram reading by radiologists to reading with the help of an FDA-approved AI tool. The goal is to see if AI improves cancer detection and reduces unnecessary callbacks. About 400,000 adult women across six U.S. health systems will participate.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 400,000 people

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

Started

Oct 2025

Expected to finish

Mar 2030

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

18 years and older

Sex

Anyone

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.

This trial will include all radiologists interpreting screening mammography and all adult patients undergoing screening mammography at any of the participating breast imaging facilities across 6 regional health systems (UCLA, UC San Diego, University of Washington-Seattle, University of Wisconsin-Madison, Boston Medical Center, and University of Miami) during the trial period. Individuals must meet the following eligiblity criteria. Inclusion Criteria: 1. Be at least 18 years of age or older 2. Receive a screening mammogram at one of the participating breast imaging facilities OR be a radiologist who interprets screening mammograms at one of the participating breast imaging facilities. Exclusion Criteria: 1\. Patients who have opted out of all research at the health system

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As listed by the trial registrant

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

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • University of California Los Angeles Health System

    RECRUITING

    Los Angeles, California, 90024, United States

  • University of California, San Diego

    RECRUITING

    San Diego, California, 92093, United States

  • University of Miami Health System

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Washington Health System

    RECRUITING

    Seattle, Washington, 98195, United States

  • University of Wisconsin-Madison

    RECRUITING

    Madison, Wisconsin, 53706, United States

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