Intraoperative Sonographically Guided Resection of Gliomas Not Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Extent of resection in percents
研究概览
简要总结
The purpose of the study is to determine whether intraoperative ultrasound guided resection of glioma without contrast enhancement in magnetic resonance imaging can achieve higher extent of resection than surgery without intraoperative sonography
详细描述
Gliomas, not enhancing contrast agent in magnetic resonance imaging (MRI), are usually low-grade gliomas. They rarely show intraoperative fluorescence using 5-aminolevulinic acid or fluorescein. Intraoperative high-field MRI, sonography and navigation are the only ways to assess extent of their resection during surgery. MRI is the gold standard, but interrupts surgical workflow and only few hospitals are equipped with device like that. Navigation eventually looses it's precision due to brainshift. Ultrasound allows assess tumor remnants in real time but has worse imaging quality. Currently no randomized trials published their results about efficiency of intraoperative sonography in removing low-grade gliomas.
Objective of the study is to determine whether intraoperative ultrasound guided resection of non-enhancing gliomas can achieve higher extent of resection than surgery without intraoperative sonography.
Participants of the study will be randomly operated with and without intraoperative ultrasound. 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
Glioma 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 supratentorial gliomas without contrast enhancement in preoperative magnetic resonance imaging (presumed low-grade gliomas)
- •newly diagnosed
- •previously untreated
- •Karnofsky Performance Status 60-100%
- •age 18-79 years
- •performed magnetic resonance imaging with contrast enhancement
排除标准
- •glioma spreading to brainstem
- •previously performed radiotherapy, chemotherapy or immunotherapy
- •planned supratotal tumor resection until neurophysiologically revealed eloquent areas
结局指标
主要结局
Extent of resection in percents
时间窗: within 48 hours after surgery
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
次要结局
- Gross total resection (Yes or No)(within 48 hours after surgery)
- Speech function (in grades)(within 10 days after surgery)
- Cerebral complications(From admission to intensive care unit after surgery till hospital discharge, up to 365 days)
- Motor function (in grades)(within 10 days after surgery)
- Karnofsky Performance status in percents(within 10 days after surgery)
研究者
Alexander Dmitriev
Neurosurgeon, MD
Sklifosovsky Institute of Emergency Care