Recruiting

Precision Supplemental Imaging in Women With Dense Breasts

ClinicalTrials.gov IDNCT07277738

PhaseNA

Enrollment78

SponsorWashington University School of Medicine

Age25 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer, Cancer of the Breast

About this study

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.

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

Primary outcomes

Number of successful recommendations for MRI (Feasibility portion only) (Through completion of follow-up (estimated to be 24 months))
2-year detection rate (Randomized Controlled Trial only) (2 years)

Eligibility information

Inclusion Criteria: * Normal screening mammogram within 90 days prior to enrollment. Bi-Rads of 1 or 2. * 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") * Assigned female at birth. * Between 40 to 74 years of age (inclusive). * Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: * Screening mammogram with BI-Rads of 0. * 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 non-classic 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 endocrine therapy. * Has breast implants. * Is breastfeeding.

Study locations

Washington University School of Medicine, St Louis, Missouri 63110 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.