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NCT04904757 | UNKNOWN | Mammographic Breast Density

Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening
Sponsor:

University of Virginia

Information provided by (Responsible Party):

Matthew Miller, MD PhD

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.

Condition or disease

Mammographic Breast Density

Mammography

Intervention/treatment

Contrast-enhanced spectral mammography (CESM)

Phase

NA

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 related to the use of CESM for breast cancer screening. For this study, 210 women with heterogeneous or dense breast tissue reported on a previous mammogram, will be recruited to undergo a screening Contrast-enhanced Spectral Mammography (CESM). The CESM will serve as the subject's annual screening breast exam for clinical care. A survey will be administered before and after the examination that evaluates the patient experience. Women will not be at high risk for breast cancer (\<20% lifetime risk). All abnormal findings will be acted upon independently. Results of the general screening population survey will be compared with those of women who choose to undergo the CESM examination in order to evaluate the influence of age, education, and lifetime risk on decision making about advanced screening.

Study Type : INTERVENTIONAL
Estimated Enrollment : 210 participants
Masking : NONE
Primary Purpose : 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
Actual Study Start Date : 2019-09-19
Estimated Primary Completion Date : 2022-12
Estimated Study Completion Date : 2023-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 69 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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
Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening

Location Details

NCT04904757

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Virginia

UVA Breast Care Center

Charlottesville, Virginia, United States, 22911