Evaluating Contrast-enhanced Spectral Mammography for Breast Cancer Screening
Willingness of Women to Undergo a Contrast-enhanced Spectral Mammography (CESM) for Breast Cancer Screening and Their Experience Before and After CESM
This study is testing whether women with dense breast tissue prefer Contrast-enhanced Spectral Mammography over regular mammograms for their annual breast cancer screening.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 40 Years to 69 Years |
| Sex | Female |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT04904757 on ClinicalTrials.gov |
What this trial studies
This study aims to assess how well women adopt Contrast-enhanced Spectral Mammography (CESM) as their annual breast cancer screening method compared to traditional 2-D or 3-D mammograms. It will involve 210 women aged 40 to 69 with dense breast tissue who will undergo CESM as part of their clinical care. Participants will complete surveys before and after the CESM to evaluate their experience and decision-making factors related to advanced screening. The study will compare the experiences of those who choose CESM with those who opt for standard mammography.
Who should consider this trial
Good fit: Ideal candidates are women aged 40 to 69 with heterogeneous or extremely dense breast tissue who have had a normal mammogram in the past 24 months.
Not a fit: Patients who may not benefit include those with a history of high breast cancer risk, certain medical conditions, or those who have not had a mammogram in the last 24 months.
Why it matters
Potential benefit: If successful, this study could lead to improved breast cancer screening practices and better patient outcomes for women with dense breast tissue.
How similar studies have performed: While CESM is FDA approved, the adoption into clinical practice has been slow, indicating that this approach may be novel in terms of evaluating patient acceptance and experience.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Female * 40 to 69 years * Previous normal mammogram (BI-RADS 1 or 2) showing heterogeneous or extremely dense breast tissue within last 24 months * Scheduled for screening mammogram as part of the patient's clinical care Exclusion Criteria: * • No mammogram within last 24 months * Fatty or scattered fibroglandular tissue on last mammogram * History of allergy to iodinated contrast * History of renal disease or renal function abnormalities * Pregnant women * History of diabetes * History of paraproteinemia syndromes such as multiple myeloma * History of collagen vascular disease * History of vascular disease (coronary artery disease, myocardial infarction, carotid disease, peripheral vascular disease, or known visceral artery disease) * Previously identified as high risk for breast cancer (\>20% lifetime risk) * Asthma * Sickle Cell Anemia * Currently on Dialysis
Where this trial is running
Charlottesville, Virginia
- UVA Breast Care Center — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Kathy L Repich, RN
- Email: klr3b@virginia.edu
- Phone: 4342434540
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.