Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-69
SponsorUniversity of Virginia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• 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
Disqualifiers
• 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
Trial design
Design model
Single group
Treatments tested in this trial
Contrast-enhanced spectral mammography (CESM)
DeviceCESM 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.
Treatment groups
210 Participants
are divided into 1 treatment groupGroup A: CESM Pre and Post SurveyOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
16 monthsSecondary outcomes
1
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.
Time frame
16monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov