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Can a risk score and MRI outsmart dense breasts?

NCT ID NCT07277738

Diagnosis Sponsor: Washington University School of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 5 times

Summary

This study looks at whether adding an MRI to the yearly mammogram can help find breast cancer earlier in women with dense breasts. Participants will have a mammogram and a risk score calculated from it. Those with a high risk score will be offered an MRI. The goal is to see if this approach reduces cancers found between screenings or at a later stage.

What this could mean

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

Active substance
Prognosia Breast (a mammogram-based risk algorithm) and MRI
What this could lead to
If successful, this could show that using a risk score to select women for supplemental MRI reduces late-stage or interval breast cancers.
What could go wrong
This is a small, early feasibility study (78 participants) and not yet recruiting. The risk score may not accurately predict who benefits from MRI, and MRI can lead to false alarms or unnecessary biopsies.

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 78 people

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

Started

Sep 2026

Expected to finish

Sep 2029

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

25 to 55 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: * Normal screening mammogram within 90 days prior to enrollment. Bi-Rads of 1 or 2. * Dense breasts, either: * Class C density ("the breasts are heterogeneously dense, which may obscure small masses") * Class D density ("the breasts are extremely dense, which lowers the sensitivity of mammography") * Assigned female at birth. * Between 40 to 74 years of age (inclusive). * Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: * Screening mammogram with BI-Rads of 0. * Contraindication to MRI with contrast (e.g. claustrophobia, metal objects in the body, known sensitivity/allergy to gadolinium). * Prior or concurrent malignancy whose natural history has the potential to interfere with the study intervention (breast cancer or non-classic LCIS). Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial. * Prior MRI screening of the breast. * Known to be BRCA 1/2 positive or presence of any other known high penetrance genetic marker. * Is receiving any endocrine therapy. * Has breast implants. * Is breastfeeding.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

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

Breast cancer Cancer of the breast

How to take part

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

  1. The places running it

    1 site. 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

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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