Confocal Laser Endomicroscopy for Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Identification of tumor tissue
研究概览
简要总结
The prognosis of glioblastoma patients highly depends on resection extent. Various strategies have been introduced to overcome the dilemma of intraoperative tumor identification.
In gastroenterology, confocal laser endomicroscopy (CLE) allows precise differentiation of tumor tissue from surrounding mucosa in various diseases. Combining high-definition white light endoscopy with CLE significantly increases sensitivity and specificity compared with the sole application of high-definition white light endoscopy.
CLE was recently introduced to neurosurgical applications. Although still in an early stage of clinical application, this technique has proven to be capable of differentiating various tumor entities in animal models as well as human tissue samples. CLE allows visualization of the underlying tissue on a microscopic scale, receiving information on the microstructure as well as cellular components. However, the clinical importance of this technique for its application in neurosurgery will be demonstrated in this clinical trial.
详细描述
Background:
The prognosis of glioblastoma patients highly depends on resection extent. Various strategies have been introduced to overcome the dilemma of intraoperative tumor identification.
In gastroenterology, confocal laser endomicroscopy (CLE) allows precise differentiation of tumor tissue from surrounding mucosa in various diseases. Combining high-definition white light endoscopy with CLE significantly increases sensitivity and specificity compared with the sole application of high-definition white light endoscopy.
CLE was recently introduced to neurosurgical applications. Although still in an early stage of clinical application, this technique has proven to be capable of differentiating various tumor entities in animal models as well as human tissue samples. CLE allows visualization of the underlying tissue on a microscopic scale, receiving information on the microstructure as well as cellular components. However, the clinical importance of this technique for its application in neurosurgery still needs to be demonstrated
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •The patient is undergoing neurosurgery for a suspected brain tumor and amenable to surgical resection by fluorescent guided technique
- •The patient has an indication for tumor resection
- •Macroscopic tumor visualization using sodium fluorescein is planned, concentration 5-10mg/kg
- •The patient is older than 18 years
- •Written consent
排除标准
- •Stereotactic biopsy procedure
- •Patients with any kind of contraindication to the use of fluorescein sodium
- •Vulnerable persons (pregnant women, patients with Glasgow Coma Scale below 14)
- •Participation in other ongoing clinical trials with one exception: double inclusions are allowed provided that no interaction with NaF is to be expected
- •People who do not want to participate in the study
- •Tumors that do not exactly match the inclusion criteria
- •Emergency procedures in which no consent was obtained before the operation.
- •Multiple surgeries on the same patient.
结局指标
主要结局
Identification of tumor tissue
时间窗: End of surgery
Identification of tumor tissue versus non-affected tissue by the CONVIVO system in comparison to the histopathology of frozen section
次要结局
- Rate of unclear visualizations(14 days after surgery)
- Accuracy of CONVIVO results(14 days after surgery)
- Time for tissue visualization with the CONVIVO system(End of surgery)