- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04904757
Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening (S-CESM)
Willingness of Women to Undergo a Contrast-enhanced Spectral Mammography (CESM) for Breast Cancer Screening and Their Experience Before and After CESM
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kathy L Repich, RN
- Phone Number: 4342434540
- Email: klr3b@virginia.edu
Study Contact Backup
- Name: Matthew M Miller, MD
- Email: MM5CA@hscmail.mcc.virginia.edu
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22911
- Recruiting
- UVA Breast Care Center
-
Contact:
- Kathy Repich
- Phone Number: 434-825-3112
- Email: klr3b@virginia.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: CESM Pre and Post Survey
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:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the patient experience during a screening CESM
Time Frame: 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. |
16 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
determine if there is an association between the willingness to undergo CESM and age, level of education, and breast cancer related risk factors.
Time Frame: 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. |
16months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB#18853
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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