Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening
Recruiting · NCT04904757 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Virginia
View the official record on ClinicalTrials.gov →Interventions studied
Contrast-enhanced spectral mammography (CESM)
What this trial is about
The purpose of this study is to evaluate how well women may adopt a Contrast-enhanced Spectral Mammography (CESM) as their yearly breast screening test compared to the standard 2-D or 3-D mammogram.
Who can take part
Age range
40 Years to 69 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- UVA Breast Care Center - Charlottesville, Virginia, United States