Actively Recruiting
Willingness of Women to Undergo a Contrast-enhanced Spectral Mammography (CESM) for Breast Cancer Screening and Their Experience Before and After CESM
Led by University of Virginia · Updated on 2022-11-17
210
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well women may choose to use Contrast-enhanced Spectral Mammography (CESM) as their yearly breast cancer screening compared to the standard 2-D or 3-D mammogram. This study focuses on women with heterogeneous or dense breast tissue reported on a previous mammogram and who are not at high risk for breast cancer. The study aims to understand patient experiences and decision-making factors such as age, education, and lifetime risk in adopting CESM screening. The study involves 210 women who will undergo a screening CESM exam, which includes an iodine-based contrast injection followed by two images to detect areas of increased blood flow potentially indicating cancer. The CESM exam will replace their usual annual breast screening mammogram. Participants will complete questionnaires before and after the CESM exam to assess their attitudes, concerns about contrast use, and past mammogram experiences. Participants will be involved for approximately 16 months, during which researchers will evaluate patient experiences related to CESM screening. Surveys will assess willingness to undergo CESM and its association with demographic and risk factors. Abnormal findings will be managed independently. This study includes monitoring patient feedback and learning how CESM may be integrated into routine breast cancer screening for women with dense breast tissue.
CONDITIONS
Brief Title
Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age between 40 and 69 years
- Previous normal mammogram (BI-RADS 1 or 2) showing heterogeneous or extremely dense breast tissue within the last 24 months
- Scheduled for screening mammogram as part of clinical care
You will not qualify if you...
- No mammogram within the last 24 months
- Fatty or scattered fibroglandular tissue on last mammogram
- History of allergy to iodinated contrast
- History of renal disease or abnormal kidney function
- 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 (greater than 20% lifetime risk)
- Asthma
- Sickle Cell Anemia
- Currently on dialysis
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single screening event
Participants undergo a Contrast-enhanced Spectral Mammography (CESM) as their annual breast cancer screening exam.
1 visit (in-person)
Duration - Up to 16 months
Participants complete surveys before and after the CESM exam to evaluate their experience and willingness to undergo screening.
2 visits (pre- and post-exam survey)
Trial Site Locations
Total: 1 location
1
UVA Breast Care Center
Charlottesville, Virginia, United States, 22911
Actively Recruiting
Research Team
K
Kathy L Repich, RN
M
Matthew M Miller, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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