Recruiting

Mammogram Risk Score

Sponsor:

Washington University School of Medicine

Code:

NCT07277738

Conditions

Breast Cancer

Cancer of the Breast

Eligibility Criteria

Sex: Female

Age: 25 - 55

Healthy Volunteers: Accepted

Interventions

Prognosia Breast

Mammogram

MRI

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Cancer of the Breast

Study ID

NCT07277738

Start date

Sep 9, 2026

Status verified date

Sep, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Feasibility: Recommended MRI

Consenting and eligible participants will be recommended to undergo MRI and will be followed to determine whether they complete the MRI.

experimental: Arm A: Intervention - MRI + subsequent annual screening mammogram with MRI

Consenting and eligible participants will undergo an MRI and subsequent annual screening mammogram with MRI.

active comparator: Arm B: Regular Care - annual screening mammogram

Consenting and eligible participants will undergo annual screening mammogram per standard of care.

Interventions

Prognosia Breast

The risk output from this algorithm is calibrated to US Surveillance, Epidemiology, and End Results (SEER) 5-year risk and so estimates for each woman the personal 5-year risk.

Mammogram

Standard of care annual screening mammogram

MRI

MRI at the time of annual screening mammogram

Primary outcome measure

  • Number of successful recommendations for MRI (Feasibility portion only) [ Time Frame: Through completion of follow-up (estimated to be 24 months) ]
  • 2-year detection rate (Randomized Controlled Trial only) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Tabassum Ahmad, M.D.

314-474-7696ahmad.tabassum@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Tabassum Ahmad, M.D.

314-474-7696ahmad.tabassum@wustl.edu

Principal Investigator:

Tabassum Ahmad, M.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Keywords

  • Dense breasts
  • Abbreviated MRI
  • Risk assessment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-09-16.