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Precision Supplemental Imaging for Women with Dense Breasts

This study is looking at a new way to help women with dense breasts find breast cancer earlier. It's testing a tool called Prognosia Breast, which uses your mammogram to estimate your 5-year risk of breast cancer. If your risk is high, the study will recommend an MRI (Magnetic Resonance Imaging) in addition to your regular mammogram. Researchers want to see if this approach leads to more successful MRI recommendations and improves breast cancer detection rates over two years. You might be able to join if you are a woman between 25 and 55 years old, have dense breasts (Class C or D), and a normal mammogram within the last 90 days. The study is currently unclear on its recruitment status and plans to enroll 78 participants.

Study design
This is an interventional study, meaning participants will receive specific interventions. It is a randomized controlled trial for part of the study, and aims to enroll 78 participants.
What's involved
You would have a standard annual screening mammogram and potentially an MRI at the time of your mammogram. The study involves follow-up for an estimated 24 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for an estimated 24 months after completing the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07277738

Precision Supplemental Imaging in Women With Dense Breasts

Not Yet Recruiting
NAAges 25–55InterventionalScreening
Washington University School of Medicine
~78 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Prognosia BreastMammogramMRI

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of successful recommendations for MRI (Feasibility portion only)
Measured over Through completion of follow-up (estimated to be 24 months)
+1 more outcome measured

Conditions

Breast Cancer
Cancer of the Breast

Explore related trials

Breast CarcinomaDense Breasts

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Tabassum Ahmad, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Tabassum Ahmad, M.D.
[email protected]
314-474-7696
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of successful recommendations for MRI (Feasibility portion only)Through completion of follow-up (estimated to be 24 months)

    Successful recommendation of MRI is defined as completion of MRI by women referred for MRI.

  • 2-year detection rate (Randomized Controlled Trial only)2 years

    Events including interval breast cancer or invasive breast cancer of a size ≥15mm or being lymph node positive, by arm