Clinical trial · Interventional
Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening
Willingness of Women to Undergo a Contrast-enhanced Spectral Mammography (CESM) for Breast Cancer Screening and Their Experience Before and After CESM
NCT04904757CI-TRIAL-00062225S-CESMrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mammographic Breast Density | — | UNRESOLVED | — |
| Mammography | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-enhanced spectral mammography (CESM) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- CESM Pre and Post Survey
- description
- 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: * Thoughts regarding risk of breast cancer * Concerns regarding contrast procedures such as the CESM * Past mammogram/breast imaging experience
- interventionNames
- Device: Contrast-enhanced spectral mammography (CESM)
Primary outcomes (1)
- measure
- Evaluate the patient experience during a screening CESM
- timeFrame
- 16 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.