INTRA-OPERATIVE CONFOCAL LASER ENDOMICROSCOPY FOR BRAIN TUMORS: A FEASIBILITY STUDY IN HUMAN
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To demonstrate the technical feasibility of endomicroscopic imaging during brain tumors (gliomas) removal with an open approach (classic neurosurgical procedures) and biopsies.
研究概览
简要总结
Confocal Laser Endomicroscopy (CLE) could be a useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and real-time assessment of resections margins during surgery. Probe-based CLE using the CELLVIZIO® has never been used for glioma surgical guided resection. Before assessing the potential of this technique in improving surgical resection outcome, a feasability study has to be performed.
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
- •Patients older than 18 years old
- •Clinical signs and history of the disease in favor of a HGG, LGG
- •MRI study in favor of a HGG, LGG, meningioma or brain metastasis
- •Affiliated to or beneficiary of a social security system (or equivalent).
- •Patients who have provided written informed consent for the study
排除标准
- •- Allergy to fluorescein
- •Previous life-threatening allergic reactions and known hypersensitivity
- •Pregnant or lactating or not using effective contraception;
- •Restricted renal function define by a creatinine clearance < 30ml/min
- •Patients under a beta-blockers treatment
- •Contraindication to do an MRI (pace-maker)
- •Contraindication to the use of 5-ALA : known hypersensibility to 5-ALA or to porphyrin, acute or chronic porphyria
- •Minor or adult ward of court (under guardianship or trusteeship)
- •No affiliation to a social security system (or equivalent).
- •Patients who express opposition to participation in the study.
结局指标
主要结局
To demonstrate the technical feasibility of endomicroscopic imaging during brain tumors (gliomas) removal with an open approach (classic neurosurgical procedures) and biopsies.
时间窗: End of the surgical procedure
The technical feasibility will be assessed by the capacity of the CELLVIZIO® system to provide microscopic images of healthy tissue and lesions suspected with malignancy and to match those images with classical histologies.
次要结局
- To demonstrate the safety of endomicroscopic imaging during brain tumors (gliomas, meningiomas, metastasis) removal with an open approach (classic neurosurgical procedures) and biopsies.(14 days after inclusion)