NCT01798771Unknown不适用
Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery
Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Extent of Resection
研究概览
简要总结
The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.
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
- Single (Outcomes Assessor)
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
- •adult patient (> 18 years) able to give informed consent
- •primary supratentorial intra-axial brain tumor exhibiting contrast enhancement suspected to be malignant glioma
- •tumor must be deemed completely resectable by neurosurgeon
- •diagnostic MRI
排除标准
- •patient unable or unwilling to give informed consent
- •infratentorial tumor location
- •tumor location in or near eloquent areas
- •multifocal tumor
- •existance of contraindications to undergo MRI examination
- •previous surgical treatment for an intraaxial brain tumor
结局指标
主要结局
Extent of Resection
时间窗: Early postoperative MRI within 72 hrs
The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI.
次要结局
- Volumetric extent of resection(Early postoperative MRI within 72hrs)
- PFS 6(6 months following surgery)
- PFS 12(12 months following surgery)
- Quality of life(6 months/12 months)
研究者
Dr. Christian Senft
PD Dr. med. Christian Senft
Johann Wolfgang Goethe University Hospital
研究点 (2)
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