Precision Supplemental Imaging in Women With Dense Breasts (PSID Trial)
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 range
- 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 w…
Interventions
- DevicePrognosia 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.
- DeviceMammogram
Standard of care annual screening mammogram
- DeviceMRI
MRI at the time of annual screening mammogram
Location
- Washington University School of MedicineSt Louis, Missouri