RecruitingNot ApplicableNCT04904757

Contrast-enhanced Spectral Mammography (CESM) 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


Sponsor

University of Virginia

Enrollment

210 participants

Start Date

Sep 19, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 69 Years

Inclusion Criteria4

  • • Female
  • 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 Criteria13

  • • 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

Interventions

DEVICEContrast-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.


Locations(1)

UVA Breast Care Center

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04904757


Related Trials