Clinical Study of the Utility of a Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Compare Visualized Fluroescence within brain tumors
研究概览
简要总结
5-ALA and the Orbeye surgical microscope are U.S. Food and Drug Administration (FDA) approved products. For this study, the Orbeye microscope imaging system is being used with special filters to visualize 5-ALA fluorescence. The FDA currently permits the use of these filters. The purpose of this study is to collect medical information before, during, and after standard treatment in order to better understand how to make this type of procedure accessible to patients.
This study is also being conducted to determine if use of the Orbeye equipped with these special filters improves the ability of the surgeon to remove brain tumors.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a suspected or biopsy-proven high-grade glioma (World Health Organization grade II or IV), new or recurrent.
- •Indication for craniotomy for removal of a suspected or recurrent brain tumor
- •Karnofsky Performance Scale >/- 60%
排除标准
- •Prophyria, hypersensitivity to porphyrins
- •Renal insufficiency as defined per protocol
- •Hepatic insufficiency as defined per protocol
- •Existing pregnancy (to be checked by a pregnancy test if of child-bearing age.
- •Nursing women or women using inadequate contraception
研究组 & 干预措施
Participants with known or suspected high grade gliomas
干预措施: Orbeye surgical videomicroscope (Device)
Participants with known or suspected high grade gliomas
干预措施: 5-Aminolevulinic Acid (Drug)
结局指标
主要结局
Compare Visualized Fluroescence within brain tumors
时间窗: Surgery day one
6 tissue samples will be obtained intraoperatively for each patient and assessed for 5-ALA visualization (strongly positive.weakly positive/negative). Tissue samples will be submitted for pathological assessment to determine whether tumor cells are present or absent. Visualization results will be evaluated against the pathology results (gold standard) to determine the sensitivity, specificity, positive predictive value and negative predictive value for 5-ALA visualizations with use of the ORBEYE system.
次要结局
- Volume of Residual tumor(up to 48 hours after surgery)
- Number of Patients experiencing Adverse Events(Up to 16 days after surgery)