Barrow ALA Trial for Recurrent Gliomas
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Presence of fluorescence in tumor tissue compared to tissue with treatment effect.
研究概览
简要总结
The investigators propose a single-center, non-randomized, single-arm study at the Barrow Neurological Institute/St. Joseph's Hospital for recurrent glioma. The 5-ALA for recurrent glioma study will correlate presence of fluorescence in tumor tissue with pathological findings. This will be done using three cohorts in dose escalation. The investigators' hypothesis is that (for both low- and high-grade gliomas,) a lower dose of 5-ALA will result in less false positive fluorescence.
详细描述
The goal is to determine the dose of 5-ALA which promotes the lowest volume of residual disease after resection of recurrent high grade glioma without compromising the demarcation between recurrent high grade glioma and postoperative bed normal tissue.
Sub-goals:
- To determine the impact of the dose of 5-ALA in improving volumetric extent of resection in patients with recurrent high grade gliomas
- To determine the impact of the dose of 5-ALA in improving overall survival of recurrent high grade glioma patients
- To determine the impact of the dose of 5-ALA in improving progression-free survival of recurrent high grade glioma patients
- To determine the impact of the dose of 5-ALA on the neurological morbidity of recurrent high grade glioma patients.
Patients with presumed recurrent glioma will be entered into the trial. Those with recurrent disease will receive study drug (5-ALA) in one of three dose-escalated cohorts (5 mg/kg; 10 mg/kg; 20 mg/kg). Intraoperatively, patients will undergo resection with combined fluorescence microscopy and confocal microscopy. Resected tissue specimens corresponding to the presence of fluorescence will be sent to pathology for examination. Postoperatively, patients will have an MRI with and without contrast within 48 hours of surgery. Subsequent analysis of each patient will include assessment of the primary endpoint (volume of residual disease) by volumetrically quantifying the tumor before and after surgery using T1-weighted contrast-enhancement. Similarly, volumetric extent of resection will also be measured.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
5-ala preoperatively
A dose of 5-ala will be taken by mouth approximately 3 hours before going to surgery.
干预措施: 5-ala (Drug)
结局指标
主要结局
Presence of fluorescence in tumor tissue compared to tissue with treatment effect.
时间窗: day of surgery-1 day
Correlation of fluorescence with pathological findings
次要结局
- Progression-free survival rate at 6 months(time from date of surgery to 6 months post surgery)
- Extent of resection(time within 48 hours post operative)
- Overall survival(time from date of surgery to date of death from any cause, assessed up to 100 months)