Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening

Last updated: November 16, 2022
Sponsor: University of Virginia
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04904757
IRB#18853
  • Ages 40-69
  • Female
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • • Female
  • 40 to 69 years
  • Previous normal mammogram (BI-RADS 1 or 2) showing heterogeneous or extremelydense breast tissue within last 24 months
  • Scheduled for screening mammogram as part of the patient's clinical care

Exclusion

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

Total Participants: 210
Study Start date:
September 19, 2019
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • UVA Breast Care Center

    Charlottesville, Virginia 22911
    United States

    Active - Recruiting

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