Precision Supplemental Imaging in Women With Dense Breasts
Precision Supplemental Imaging in Women With Dense Breasts (PSID Trial)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 25 Years to 55 Years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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 sites (1)
MO
- Washington University School of Medicine · St Louis, MO 63110Tabassum Ahmad, M.D. · Study contact · 314-474-7696 · ahmad.tabassum@wustl.eduTabassum Ahmad, M.D. · Principal investigatorDebbie L Bennett, M.D. · Sub-investigatorShu (Joy) Jiang, Ph.D. · Sub-investigatorMore trials in St Louis