Willingness of Women to Undergo a Contrast-enhanced Spectral Mammography (CESM) for Breast Cancer Screening and Their Experience Before and After CESM
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Evaluate the patient experience during a screening CESM
研究概览
简要总结
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.
详细描述
Contrast-enhanced spectral mammography (CESM) is an FDA approved tool for breast cancer detection. However, adoption into clinical practice has been slow. In this study, we will explore patient issues related to the use of CESM for breast cancer screening. For this study, 210 women with heterogeneous or dense breast tissue reported on a previous mammogram, will be recruited to undergo a screening Contrast-enhanced Spectral Mammography (CESM). The CESM will serve as the subject's annual screening breast exam for clinical care. A survey will be administered before and after the examination that evaluates the patient experience. Women will not be at high risk for breast cancer (<20% lifetime risk). All abnormal findings will be acted upon independently. Results of the general screening population survey will be compared with those of women who choose to undergo the CESM examination in order to evaluate the influence of age, education, and lifetime risk on decision making about advanced screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •• 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)
- •Sickle Cell Anemia
- •Currently on Dialysis
结局指标
主要结局
Evaluate the patient experience during a screening CESM
时间窗: 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.
次要结局
- determine if there is an association between the willingness to undergo CESM and age, level of education, and breast cancer related risk factors.(16months)
研究者
Matthew Miller, MD PhD
Radiology-Breast Imaging Faculty, Clinical Assistant Professor, Principal Investigator
University of Virginia