Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening

Not Applicable

Recruiting

• Conditions: Mammographic Breast Density; Mammography
• Interventions: Device: Contrast-enhanced spectral mammography (CESM)

• Registration Number: NCT04904757
• Lead Sponsor: University of Virginia

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.

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 Timeline

• Study Start: 2019-09-19
• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-17
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 210

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CESM Pre and Post Survey	Contrast-enhanced spectral mammography (CESM)	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

Primary Outcome Measures

Name	Time	Method
Evaluate the patient experience during a screening CESM	16 months	Plan for primary variable analysis: To evaluate the patient experience during a screening CESM to better understand if women find the experience of contrast injection to be too invasive or unpleasant to repeat or recommend to a friend.; Data summarization: Pre and post CESM survey responses that are binary or Likert scaled responses will be summarized by frequencies and percentages. Pre and post CESM survey responses that are continuous scaled responses will be summarized by the mean and standard deviation, the median and interquartile range, and the range of distribution.

Secondary Outcome Measures

Name	Time	Method
determine if there is an association between the willingness to undergo CESM and age, level of education, and breast cancer related risk factors.	16months	We will evaluate differences by age, education, and risk factors as to whether these drive willingness to undergo CESM.; Data summarization: Binary risk factors will be summarized by frequencies and percentages. Continuous scaled risk factors will be summarized by the mean and standard deviation, the median and interquartile range, and the range of distribution.

Trial Locations

Locations (1)

UVA Breast Care Center; 🇺🇸 Charlottesville, Virginia, United States