Clinical trial NCT04904757: Contrast-enhanced Spectral Mammography (CESM) Breast Cancer 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mammographic Breast Density
Mammography
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 210
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Evaluate the patient experience during a screening CESM
timeFrame: 16 months
Secondary outcomes:
measure: determine if there is an association between the willingness to undergo CESM and age, level of education, and breast cancer related risk factors.
timeFrame: 16months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: UVA Breast Care Center
state: Virginia
Study officials:
References: