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NOT YET RECRUITING
NCT07277738
NA

Precision Supplemental Imaging in Women With Dense Breasts

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

25 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2026-03-31

Completion Date

2029-03-31

Last Updated

2026-03-25

Healthy Volunteers

Yes

Interventions

DEVICE

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.

DEVICE

Mammogram

Standard of care annual screening mammogram

DEVICE

MRI

MRI at the time of annual screening mammogram

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States