Status:
RECRUITING
Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening
Lead Sponsor:
University of Virginia
Conditions:
Mammographic Breast Density
Mammography
Eligibility:
FEMALE
40-69 years
Phase:
NA
Brief Summary
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.
Detailed Description
Contrast-enhanced spectral mammography (CESM) is an FDA approved tool for breast cancer detection. However, adoption into clinical practice has been slow. In this study, we will explore patient issues...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
September 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04904757
Start Date
September 19 2019
End Date
June 1 2023
Last Update
November 17 2022
Active Locations (1)
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1
UVA Breast Care Center
Charlottesville, Virginia, United States, 22911