Evaluating Contrast-enhanced Spectral Mammography for Breast Cancer Screening
Official title: Willingness of Women to Undergo a Contrast-enhanced Spectral Mammography (CESM) for Breast Cancer Screening and Their Experience Before and After CESM
Run by University of Virginia · NCT04904757 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 69 Years |
| Sex | Women only |
| Enrollment | 210 (estimated) |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Status | Recruiting |
| Started | September 19, 2019 |
| Main results expected | December 2022 |
| Study ends | June 2023 |
| Registry record updated | November 17, 2022 |
| Trial ID | NCT04904757 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
UVA Breast Care Center
Charlottesville, Virginia, United States Recruiting
Study contacts
- Study coordinator: Kathy L Repich, RN
- Email: klr3b@virginia.edu
- Phone: 4342434540
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.