Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Evaluation of pain during the hospitalization (3 days)
研究概览
简要总结
the Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years.
This trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. It will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.The expected benefit is an improvement of the comfort for the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject bearing of one to five intellectual metastases of lung origin at the time of the indication of the radiosurgery
- •Subject requiring a radiosurgical treatment with LGK
排除标准
- •Subject having hurts of the brainstem or para-optics
- •Pregnant women or in feeding period
- •Subject having received previously a whole brain radiotherapy
研究组 & 干预措施
Group treated by radiosurgery with the thermoformed mask
Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast®
干预措施: MRI (Device)
Group treated by radiosurgery with stereotaxic frame
Subjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP)
干预措施: GammaKnifePerfexion® (Device)
Group treated by radiosurgery with stereotaxic frame
Subjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP)
干预措施: MRI (Device)
Group treated by radiosurgery with the thermoformed mask
Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast®
干预措施: GammaKnifeIcon® (Device)
Group treated by radiosurgery with the thermoformed mask
Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast®
干预措施: Efficast® (Device)
结局指标
主要结局
Evaluation of pain during the hospitalization (3 days)
时间窗: 12 months
Questionary (numeric pain intensity scale)
次要结局
- Evaluation of tumor control at 3 months(12 months)
- Occurrence of clinical side effects(12 months)
- Evaluation of tumor control at 6 months(12 months)