Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 40 Years and 69 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
CESM Pre and Post Survey 		Subject will be asked to complete a questionnaire that will ask you about your general attitude toward Contrast-Enhanced Spectral Mammography (CESM). Questions will include: - Thoughts regarding risk of breast cancer - Concerns regarding contrast procedures such as the CESM - Past mammogram/breast imaging experience
  • 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.

Recruiting Locations

UVA Breast Care Center
Charlottesville, Virginia 22911
Contact:
Kathy Repich
434-825-3112
klr3b@virginia.edu

More Details

Status
Recruiting
Sponsor
University of Virginia

Study Contact

Kathy L Repich, RN
4342434540
klr3b@virginia.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.