Mammography Clinical Trial
— S-CESMOfficial title:
Willingness of Women to Undergo a Contrast-enhanced Spectral Mammography (CESM) for Breast Cancer Screening and Their Experience Before and After CESM
NCT number | NCT04904757 |
Other study ID # | IRB#18853 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 19, 2019 |
Est. completion date | June 2023 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | UVA Breast Care Center | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
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 |
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