Concurrent Fluorescence and Sonographically Guided Eradication of Gliomas and Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Gross total resection (Yes or No)
研究概览
简要总结
Objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.
详细描述
Fluorescence-guided resection of contrast-enhancing gliomas and metastases increases extent of tumor resection. But the main drawback of this method is an inability to observe tumor fluorescence while it is covered with normal brain. Ultrasound can resolve this problem, allowing to reveal such tumor remnants. By the time there are published results of randomized control trials comparing these two technics.
Objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.
Participants of the study will be randomly operated using both fluorescence with 5-ALA and intraoperative ultrasound versus fluorescence with 5-ALA alone. Extent of resection will be assessed in postoperative MRI by blinded radiologists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Tumor extent of resection will be assessed by radiologists blinded for the treatment arm
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas)
- •one or several brain metastases from any cancer
- •newly diagnosed
- •Karnofsky Performance Status 60-100%
- •age 18-79 years
- •performed magnetic resonance imaging with contrast enhancement
排除标准
- •tumor spreading to corpus callosum or brainstem
- •previously performed brain radiotherapy
- •planned supratotal tumor resection until neurophysiologically revealed eloquent areas
- •known hypersensibility to 5-aminolevulinic or to porphyrin
- •hepatic or renal insufficiency
- •porphyria
- •pregnancy
- •breast feeding
结局指标
主要结局
Gross total resection (Yes or No)
时间窗: within 48 hours after surgery
No residual contrast enhancement in postoperative T1-weighted magnetic resonance imaging
次要结局
- Cerebral complications(From admission to intensive care unit after surgery till hospital discharge, up to 365 days)
- Karnofsky performance status (in percents)(within 10 days after surgery)
- Extent of resection (in percents)(within 48 hours after surgery)
- Motor function (in grades)(within 10 days after surgery)
- Speech function (in grades)(within 10 days after surgery)
研究者
Alexander Dmitriev
Neurosurgeon, MD
Sklifosovsky Institute of Emergency Care