Adjoint Intra-operative Confocal Laser Endomicroscopy (CLE) to Present Tissue on the Cellular Level in Defined Lesions of the Central Nervous System (CNS) During Medically Induced Neurosurgery in Subcranial Tumors and Glioma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- post-surgery comparison of in-vivo tissue characterization with ex-vivo histocytopathology
研究概览
简要总结
Purpose of the study is to answer the question whether confocal laser endomicroscopy (CLE, also named 'optical biopsy') might improve the results of medically necessary neurosurgery to prove practicability, safety and harmlessness of CLE during neurosurgical procedures
详细描述
In patients requiring neurosurgical oncological Intervention using endoscopic devices, a mini laser probe will be administered through the endoscopic device to characterize in vivo the tissue by thousandfold magnification down to the cellular level (so-called optical biopsy). Magnification is presented to the neurosurgeon in time to better differentiate between healthy and pathological tissue. Post-surgery results of in-vivo Differentiation will then be compared to histocytopathological findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients administered to the department of neurosurgery requiring neurosurgery due to either diagnosed gliomata (40 patients) or diagnosed subcranial tumors adjacent to or already invading neuronal structures (20 patients)
- •patients having given informed consent
排除标准
- •severe concomitant diseases probably negatively influencing the participation in this clinical trial
- •cardial infarction or stroke within the preceding 12 months
- •Treatment resistant hypertonus (systolic blood pressure >200 mmHg or diastolic blood pressure >120 mmHg or a combination of both
- •Pulmonic diseases that might result in an advanced risk for anesthetic measurements
- •Patients being vaccinated with live vaccines (14 days Prior) or contra Influenza (7 days Prior) to start of the study
- •All concomitant findings that might increase in the eyes of the investigator the risk of participation
结局指标
主要结局
post-surgery comparison of in-vivo tissue characterization with ex-vivo histocytopathology
时间窗: duration of hospital stay, an expected average of 7 days
次要结局
- proof of complete removal of pathologic tissue within healthy tissue(during surgical procedure, an expected average time of three hours)
- optimal tumour remission or reduction after 3 months post-surgery proven by respective diagnostic measurements(3 months post surgery)
- Composite measure of missing iatrogenic damage of healthy neuronal structures and preservation of functionality of healthy tissue(individual post-surgery controls, an expected average of up to 7 days)