NCT07277738

Precision Supplemental Imaging in Women With Dense Breasts

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-31
• Primary completion: 2029-03-31
• Completion: 2029-03-31
• First posted: 2025-12-11
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study