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Precision Supplemental Imaging in Women With Dense Breasts | Clinical Trials | Clareo Health

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Precision Supplemental Imaging in Women With Dense Breasts

Precision Supplemental Imaging in Women With Dense Breasts (PSID Trial)

NCT07277738•Washington University School of Medicine

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.

Eligibility

Age

25 - 55 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Normal screening mammogram within 90 days prior to enrollment.
•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")
•MRS risk estimate at \> 3% 5-year risk of breast cancer.
•Female.
•Between 25 and 55 years of age (inclusive).
•Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria

•More than 1 prior mammogram
•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 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 chemoprevention.
•Has breast implants.
•Is breastfeeding.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

March 31, 2026

Primary Completion Date

March 31, 2029

Completion Date

March 31, 2029

Last Updated

February 4, 2026

Enrollment

ESTIMATED participants

Conditions

Breast CancerCancer of the Breast

Interventions

Prognosia Breast

DEVICE

Mammogram

DEVICE

MRI

DEVICE

Contacts

Tabassum Ahmad, M.D.

CONTACT

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

Graham A Colditz, M.D., DrPH

CONTACT

314-454-7939 colditzg@wustl.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Precision Supplemental Imaging in Women With Dense Breasts

Inclusion Criteria

Exclusion Criteria

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