NCT07277738 · Washington University School of Medicine
Precision Supplemental Imaging in Women With Dense Breasts
(PSID)
What this study is about
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).
View original scientific description
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 outcome measures
Number of successful recommendations for MRI (Feasibility portion only)
Time frame: Through completion of follow-up (estimated to be 24 months)
Successful recommendation of MRI is defined as completion of MRI by women referred for MRI.
2-year detection rate (Randomized Controlled Trial only)
Time frame: 2 years
Events including interval breast cancer or invasive breast cancer of a size ≥15mm or being lymph node positive, by arm
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- St Louis, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 16, 2026 · Source of record for eligibility and locations