Recruiting
Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening
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.
ClinicalTrials.gov IDNCT04904757
PhaseNA
Enrollment210
SponsorUniversity of Virginia
Age40 Years
SexFEMALE
Conditions studied
Mammographic Breast Density, Mammography
About this study
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.
Interventions
- Device: Contrast-enhanced spectral mammography (CESM) — CESM is a mammogram performed after the injection of IV contrast. CESM is used most often when additional information is needed after a standard mammogram. CESM has also been used to determine the extent of a known breast cancer, to screen patients at high risk for developing breast cancer due to a family history or positive cancer genes, and for women with dense breast tissue. Two images are taken almost at the same time during the exam, after the iodine based contrast injection is administered. The first image is comparable to a regular mammogram. The second image shows areas that take up the contrast (enhance) showing increased blood flow. Breast cancers often enhance with contrast due to a greater amount of blood vessels. Non-cancerous lesions can also have greater blood flow.
Primary outcomes
- Evaluate the patient experience during a screening CESM (16 months)
Eligibility information
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
Study locations
- UVA Breast Care Center, Charlottesville, Virginia 22911 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.