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Precision Supplemental Imaging in Women With Dense Breasts

Washington University School of Medicine · NCT07277738

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 25–55 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
78
US sites recruiting
1
Study start
September 9, 2026
Record last updated
September 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Recent research has shown that, among women with extremely dense breasts and normal results on mammogram, magnetic resonance imaging (MRI) use has significantly reduced the occurrence of breast cancer that is diagnosed during the time between two regular screening mammograms (also known as interval cancers).

The investigators have developed and validated an approach to use the whole mammogram image, develop a mammogram risk score (MRS), and calibrate this to the SEER breast cancer incidence rates for US women. This model (Prognosia Breast) generates an absolute 5-year risk of breast cancer and classifies approximately 5.7% of the population as high risk using the ASCO 3% cut point as used for endocrine therapy to reduce risk. Follow-up generates an incidence of 25.2 cases per 1,000 women per year.

Being studied: Prognosia Breast; Mammogram; MRI

Conditions: Breast Cancer; Cancer of the Breast

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Washington University School of Medicine

    St Louis, MO 63110

    Site contact: Tabassum Ahmad, M.D. · 314-474-7696 · ahmad.tabassum@wustl.edu

Study contacts (from the official record)

  • Tabassum Ahmad, M.D. · 314-474-7696 · ahmad.tabassum@wustl.edu
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Precision Supplemental Imaging in Women With Dense Breasts (NCT07277738) | Bored Studies