Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening

Mammography Clinical Trial

— S-CESM  

Official title:

Willingness of Women to Undergo a Contrast-enhanced Spectral Mammography (CESM) for Breast Cancer Screening and Their Experience Before and After CESM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904757
• Other study ID #: IRB#18853
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2019
• Est. completion date: June 2023

Study information

• Verified date: November 2022
• Source: University of Virginia
• Contact: Kathy L Repich, RN
• Phone: 4342434540
• Email: klr3b[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Mammographic Breast Density
• Mammography

Intervention

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.

Locations

Country	Name	City	State
United States	UVA Breast Care Center	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the patient experience during a screening CESM	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.	16 months
Secondary	determine if there is an association between the willingness to undergo CESM and age, level of education, and breast cancer related risk factors.	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.	16months

External Links

•   Contrast-Enhanced mammography Screening for women with dense breast tissue