The Clinical Evaluation of the Stereotactic, MR Guided, Laser Interstitial Thermal Therapy (LITT ) for the "Minimal Invasive" Treatment of Brain Metastasis and Primary Brain Tumors - a Phase I Study With Direct Patient Benefice
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- BioTex, Inc.
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- 12 month morbidity and mortality
研究概览
简要总结
The purpose of this study is to determine if the stereotactic, MR guided, laser interstitial thermal therapy treatment technique can be safety and efficiently used for human brain metastasis and primary brain tumors.
详细描述
This new "minimally invasive" technique has been tested so far, with success, on animal brain tumor models and on human liver metastasis.
The main purpose of this study is to determine if the stereotactic, MR guided, laser interstitial thermal therapy treatment technique can be safety and efficiently used for the human brain metastasis and primary brain tumors.
As secondary objectives for this clinical study, the following are to be explored:
- Eventual evaluation of the eventual mid and long term post-intervention complications,
- Evaluate the contra indication for the technique,
- Evaluate and optimize clinical and logistic intervention protocols,
- Evaluate the mean duration for the procedure,
- Evaluate the mean cost for the procedure
The clinical trial will include a statistical sample of 12-18 treatments and will run over a period of 18 months. The inclusion period will be for 6 months and the patients will be followed up during 12 months post intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients 18 years of age or older
- •Patients with brain metastasis located in the brain hemispheres
- •Patient with a brain metastasis smaller or equal to 4 cm in diameter
- •Patient with primary brain tumor smaller or equal to 4 cm in diameter
- •Patient previously treated with other therapeutic techniques ( radio-therapy, chemotherapy, immunotherapy) which have failed.
排除标准
- •Patients less than 18 years old,
- •Patients presenting contra indication for MRI studies
- •Patient for which the primary cancer is melanoma or kidney tumors
- •Patients having a mean life duration longer than 3 months (due to the primary cancer)
结局指标
主要结局
12 month morbidity and mortality
次要结局
- Mid and long term post-intervention complications,
- Mean procedure cost
- Contra indication for the technique,
- Optimize clinical and logistic intervention protocols,
- Mean procedure duration