In Vivo Confocal Endomicroscopy of the Brain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To test of the ability of the surgeon to obtain interpretable images during surgery.
研究概览
简要总结
The purpose of the study is to test the feasibility of obtaining interpretable in vivo endomicroscopy images which can be compared with traditional histopathology.
Hypothesis: That a rigid confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables differentiation of tumour tissue from normal adjacent brain tissue.
详细描述
Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. It is already in clinical use in the fields of gastroenterological endoscopy, laparoscopy, dermatology, gynecology and respiratory medicine. This study represents the first time that confocal endomicroscopy will be evaluated for intraoperative imaging in neurosurgery.
The procedure involves a small endoscope which is placed gently into contact with the brain, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. The captured confocal images will be compared with corresponding histology (tissue that is being removed as part of the indicated neurosurgical procedure). The images will be visually compared among each other and with histology images to detect possible clinically relevant information.
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
- •All patients with neurosurgical pathology requiring surgery in which tumor resection might be evaluated by using biopsy.
排除标准
- •Pregnant women
- •Inability to give informed consent
- •History of allergy to fluorescein
- •Patients on beta-blockers or ACE inhibitors
结局指标
主要结局
To test of the ability of the surgeon to obtain interpretable images during surgery.
时间窗: During surgery
次要结局
- To correlate the in vivo endomicroscopy images with traditional histopathology.(one week)
- To evaluate the usability of the device in the OR environment.(During surgery)