Quantification of ALA-induced PpIX Fluorescence During Brain Tumor Resection
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology
研究概览
简要总结
Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of the patient's tumor by looking at the MRI images that were taken of the patient's brain before surgery. However, the surgeon does not have any good way to tell if the entire tumor has been removed or not. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease the chances of survival.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative diagnosis of either presumed first-time low or high grade glioma, or recurrent glioma, or metastasis, or meningioma
- •Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
- •Patient or LAR able to provide written informed consent.
- •No serious associated psychiatric illnesses.
- •Age > 21 years old.
排除标准
- •Pregnant women or women who are breast feeding
- •History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis.
- •History of liver disease within the last 12 months.
- •Elevated liver function levels greater than 2.5 times the normal limit from laboratory tests conducted within 30 days prior to surgery.
- •Inability to comply with the photosensitivity precautions associated with the study.
- •Plasma creatinine in excess of 180umol/L within 30 days prior to surgery
研究组 & 干预措施
Experimental: 5-aminolevulinic acid
20mg/kg 3 hours prior to surgery
干预措施: 5-aminolevulinic acid (Drug)
结局指标
主要结局
Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology
时间窗: Up to five years from the first surgery date
To estimate the probability of tumor distribution for a given PpIX concentration by comparing intraoperative measurements with coregistered histopathology obtained from biopsy sampling during the procedure
次要结局
未报告次要终点
研究者
David W. Roberts
Professor of Surgery (Neurosurgery)
Dartmouth-Hitchcock Medical Center