Fluorescence Spectroscopy Guided Surgery for Brain Tumors Resection: a Feasibility Study in Human
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Assessment of the feasibility by calculating the ratio of normalized fluorescence intensity measured at 620 nm and at 634 nm
研究概览
简要总结
Intraoperative surgical fluorescence microscopy is a useful technique for the surgical resection of glioma. However the accuracy of this method is limited by its too low sensitivity. Fluorescence spectroscopy has the potential capacity to overcome the current limitations of conventional fluorescence guided surgery by increasing the sensitivity: in a pilot study on brain tumor biopsies, fluorescence spectroscopy was shown to measure two-peaked 5-ALA-induced protoporphyrin IX (PpIX) fluorescence emission spectrum which clearly enables to distinguish the solid component of glioblastomas from low grade gliomas and infiltrative component of glioblastomas. This innovative method could become in future 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. However, those preliminary ex-vivo results have to be confirmed in a feasibility in-vivo study on human.
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
- 19 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
- •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
Assessment of the feasibility by calculating the ratio of normalized fluorescence intensity measured at 620 nm and at 634 nm
时间窗: 1 day (End of the surgical procedure)
The technical feasibility will be assessed by the capacity of the prototype to provide distinguished fluorescence emission spectrum depending on the tumor component (correlation between the spectrum and classical histology).
次要结局
- Assessment of the safety as a composite outcome measure : number, type and severity of recorded adverse events(14 days after inclusion)