Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening
研究概览
简要总结
This research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening
详细描述
Mammography is the main way to help find breast cancers early so they can be treated. Unfortunately, mammography does not work as well in women who have dense breast tissue or who are at high-risk for breast cancer. In these women, breast MRI is also used to help find breast cancers.
Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone. This is similar to breast MRI.
For this study, participants who had both CEM and MRI evaluating a finding that initiated from a screening exam will be included. Radiologists will compare the images to see if the contrast enhanced mammograms and the breast MRI find the same number of breast cancers. If the investigators find they perform similarly, then contrast mammography may be used to aid in breast cancer screening in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 110 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •CESM and MRI exam performed within 3 months of one another.
- •CESM and breast MRI exams must be performed as part of imaging work-up based on a screening exam of any type (mammography, tomosynthesis, ultrasound, and MRI)
- •CESM studies will include at least four low energy and four recombined images (LCC, LMLO, RCC, RMLO).
- •MRI exams will include at least fluid sensitive sequence, multi-phase T1-weighted
排除标准
- •Imaging sets with implants.
- •Imaging sets in which a biopsy or surgical intervention was performed since the most recent screening exam, prior to acquisition of the study MRI or CESM.
- •Imaging sets in which a biopsy was recommended, but biopsy was not performed and 2 year imaging follow-up is not available
结局指标
主要结局
Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening
时间窗: 2 years
We will determine whether CESM is non-inferior to breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model.
次要结局
- Area Under the Curve for Cancer Detection Rates of CESM Compared With Abbreviated Breast MRI for Breast Cancer Screening(2 years)
- Area Under the Curve for Cancer Detection Rates of CESM Compared With Conventional 2d Mammography for Breast Cancer Screening(2 years)
研究者
Olga Brook
Vice-Chair of Research
Beth Israel Deaconess Medical Center