NCT04556929终止不适用
Improving Fluorescence-guided Brain Tumour Surgery With Ultra-high Sensitivity Imaging
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Level of tumour fluorescence in images of resection cavity captured during surgery
研究概览
简要总结
The purpose of this study is to determine whether use of an ultra-high sensitivity camera with enhanced imaging technology can be used during surgery to detect areas of brain tissue affected by diffuse glioma, a type of brain cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •Female patients are not pregnant at time of surgery.
- •Patient has consented to craniotomy for suspected glioma of any type with 5-ALA infusion.
排除标准
- •Participants are participating in another trial at time of operation
结局指标
主要结局
Level of tumour fluorescence in images of resection cavity captured during surgery
时间窗: Intra-operative
Levels of tumour fluorescence in intra-operative images of the resection cavity taken by the ultra-high sensitivity camera and the in-built camera in the operative microscope will be measured. These fluorescence levels will then be used to calculate the sensitivity and specificity of the in-built camera and ultra-high sensitivity camera to detect glioma tissue.
次要结局
- Duration of operation stages(Intra-operative)
研究者
研究点 (2)
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