Precision MRI screening for dense breasts using Prognosia Breast risk score

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial uses a whole-mammogram approach to generate a Prognosia Breast risk score calibrated to US incidence rates. Women aged 40–74 with dense breasts and BI-RADS 1–2 on a recent mammogram, who have normal results and are able to undergo MRI with contrast, are eligible. Participants will receive MRI screening guided by their individualized 5-year risk estimate to see if this approach lowers cancers detected between routine screenings. The study builds on prior findings that MRI can reduce interval cancers in dense breasts and aims to validate this personalized imaging strategy in a real-world setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Tabassum Ahmad, M.D. — Washington University School of Medicine
• Study coordinator: Tabassum Ahmad, M.D.
• Email: ahmad.tabassum@wustl.edu
• Phone: 314-474-7696

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.