Precision Supplemental Imaging in Women With Dense Breasts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prognosia Breast, Mammogram, MRI.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Cancer of the Breast. Basic parameters: 25 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Precision Supplemental Imaging in Women With Dense Breasts (PSID Trial)
Overview
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)]
- 2-year detection rate (Randomized Controlled Trial only) [Time frame: 2 years]
Secondary outcome measures (5)
- Sample size for randomized controlled trial (Feasibility portion only) [Time frame: Through completion of follow-up (estimated to be 24 months)]
- Number and percentage of recalls (Feasibility portion only) [Time frame: Through completion of follow-up (estimated to be 24 months)]
- Positive predictive value for recall for additional testing and biopsy (Feasibility portion only) [Time frame: Through completion of follow-up (estimated to be 24 months)]
- Number and percentage of recalls (Randomized Controlled Trial only) [Time frame: Through completion of follow-up (estimated to be 24 months)]
- Positive predictive value for recall for additional testing and biopsy (Randomized Controlled Portion only) [Time frame: Through completion of follow-up (estimated to be 24 months)]
Eligibility criteria
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 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 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 chemoprevention.
- Has breast implants.
- Is breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT07277738 · 202511123