NCT00977327Unknown不适用
Comparison of Two Neuro-navigational Systems for Resection-control of Intra-axial Brain Tumors. The PoleStarN-20 Intra-operative Magnet Resonance Imager and the Mison SonoWand Intra-operative Ultrasound System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The primary end point of the study is assessment and comparison of intra-operative Magnet Resonance Imaging and ultrasound to better define its impact on the extent of resection.
研究概览
简要总结
Purpose:
- Improvement of extent of resection by the use of intraoperatively acquired image data sets to navigate.
- Better define the role of different intra-operative imaging modalities, used to update the navigational data set, in aiding the surgeon during resection of intra-axial brain lesions.
- To examine the cost-effectiveness of different intraoperative navigational systems as a function of operative time and Operative time (Surgery including imaging)
There is increasing neuro-oncological evidence that extent of resection might have an impact in particular in low-grade lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 must have neuro-radiological evidence of a brain lesion. Eligible are all histological types of brain lesions.
- •> 18 years of age.
- •Male and female.
- •Patient must be a surgical candidate, according to general anesthetic and neurosurgical criteria.
- •Patient should be able to undergo MRI.
- •Informed consent as per protocol.
排除标准
- •Patient unwilling to undergo surgery for resection of brain tumor.
- •Patient medically not eligible to undergo craniotomy. (Medical contraindication).
- •Patient has a medical contraindication or is unwilling to undergo MRI scanning (pacemaker, other metal device ot parts in head or body,).
- •Kidney function compromise (Creatinine values > 1.4 mg/dL).
研究组 & 干预措施
Intraoperative Ultrasound
Other
Use of intraoperative ultrasound during resection of intraaxial tumor, Glioma
干预措施: Intraoperative Ultrasound (Sonowand, Mison) (Device)
Intraoperative MR
Other
Use of intraoperative MR during resection of intraaxial tumor, Glioma
干预措施: Intraoperative MR (PoleStar N-20, Medtronics) (Device)
结局指标
主要结局
The primary end point of the study is assessment and comparison of intra-operative Magnet Resonance Imaging and ultrasound to better define its impact on the extent of resection.
时间窗: 72 hours
次要结局
- Secondary end points should identify criteria for selecting the right system for a specific patient (Patient selection), and cost-effectiveness.(3-6 months)
研究者
研究点 (1)
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