Feasibility Study of Breast MRI in Decubitus Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Percentage of lesions where the topography is discordant between the positions (prone and supine).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age < 18 years old
- •Claustrophobia
- •Contraindication to the injection of contrast medium Gadoline
- •Contraindication to MRI
- •Persons deprived of liberty or under supervision
研究组 & 干预措施
Supine position
3.0 tesla MRI in supine position
干预措施: Position for the 3.0 Tesla in Magnetic Resonance Imaging (Procedure)
Prone position
3.0 tesla MRI in prone position
干预措施: Position for the 3.0 Tesla in Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Percentage of lesions where the topography is discordant between the positions (prone and supine).
时间窗: 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.
次要结局
- Comfort patient in supine position compared to the prone position using a self-administered questionnaire(1 day)
- distance from the anterior border of the lesion to the nipple in supine position compared to the prone position(1 day)
- distance from cutaneous projection of the lesion to the nipple in supine position compared to the prone position(1 day)
- distance from lesion to pectoralis major muscle in supine position compared to the prone position(1 day)
- Quandrant of the lesions and positions on a clock in supine position compared to the prone position(1 day)