Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening (S-CESM)

University of Virginia

Status: Enrolling

Conditions: Mammographic Breast Density; Mammography

Treatments: Device: Contrast-enhanced spectral mammography (CESM)

Study type: Interventional

Funder types: Other

Identifiers

NCT04904757

IRB#18853

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: Female

Ages: 40 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

CESM Pre and Post Survey

Other group

Description:

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

Treatment:

Device: Contrast-enhanced spectral mammography (CESM)