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Precision Supplemental Imaging in Women With Dense Breasts
Sponsor: 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.
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
Conditions
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
Locations (1)
Washington University School of Medicine
St Louis, Missouri, United States