Feasibility Study of Breast MRI in Decubitus Position (EFIMED)
Breast MRI is performed in prone position which causes a number of questions. Indeed, the correlation with mammography and echography and the identification of preoperative lesions can be complex as echography and surgery are carried in supine position while mammography is performed in standing position.
Moreover, the prone position is often considered as uncomfortable by the patients. However, there is few publications in the literature on breast MRI in decubitus position.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Vandoeuvre-lès-Nancy、法国、54500
- Institut de Cancerologie de Lorraine
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient to benefit a MRI in the assessment for a breast carcinoma or a suspicious of breast carcinoma
- Assessment on 3.0 Tesla in Magnetic Resonance Imaging
- Age >18 years old
- ECOG performance status ≤ 3
- Ability to provide written informed consent form
Exclusion Criteria:
- Age < 18 years old
- Claustrophobia
- Contraindication to the injection of contrast medium Gadoline
- Contraindication to MRI
- Persons deprived of liberty or under supervision
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：非随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Supine position
3.0 tesla MRI in supine position
|
Eligible patients will have a standard MRI in prone position. At the end of this examination, all patients will have an other standard MRI in supine position. This examination is then extended by 10 minutes without additional injection of contrast medium |
|
有源比较器：Prone position
3.0 tesla MRI in prone position
|
Eligible patients will have a standard MRI in prone position. At the end of this examination, all patients will have an other standard MRI in supine position. This examination is then extended by 10 minutes without additional injection of contrast medium |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of lesions where the topography is discordant between the positions (prone and supine).
大体时间：1 day
|
The topography is considered discordant if the location of the lesion is different between prone and supine positions (location will be described as the positions on a clock) and / or the distance from the nipple to the lesion is greater than 2cm between prone and supine positions.
|
1 day
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Comfort patient in supine position compared to the prone position using a self-administered questionnaire
大体时间：1 day
|
1 day
|
|
distance from the anterior border of the lesion to the nipple in supine position compared to the prone position
大体时间：1 day
|
1 day
|
|
distance from cutaneous projection of the lesion to the nipple in supine position compared to the prone position
大体时间：1 day
|
1 day
|
|
distance from lesion to pectoralis major muscle in supine position compared to the prone position
大体时间：1 day
|
1 day
|
|
Quandrant of the lesions and positions on a clock in supine position compared to the prone position
大体时间：1 day
|
1 day
|
合作者和调查者
调查人员
- 首席研究员：OLDRINI Guillaume, MD、Institut de Cancerologie de Lorraine
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2015-A00578-41
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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