Randomized Assessment of Conventional Neuronavigation Versus Intraoperative MRI for the Neurosurgical Treatment of Glioblastomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Difference in Residual tumor volume
研究概览
简要总结
The treatment of a specific subtype of highly malignant brain tumor (called "glioblastoma" or "glioblastoma multiforme") consists of neurosurgical resection, followed by radiotherapy and mostly chemotherapy as well. Increased extent of tumor resection is associated with prolonged survival. The standard treatment uses conventional neuronavigation systems to increase extent of tumor resection. However, the quality of this form of neuronavigation decreases throughout surgery because of "brain shift". This is caused by edema, loss of cerebrospinal fluid and tumor resection. A new form of neuronavigation uses intraoperative MRI to compensate for brain shift, and to check for the presence of residual tumor that can be removed.
This study aims to compare the extent of glioblastoma resection between the standard treatment and intraoperative MRI.
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)
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
- •supratentorial brain tumor, on contrast enhanced dMRI suspected to be GBM
- •indication for gross total resection (GTR) of the tumor
- •age ≥18 years
- •WHO Performance Scale ≤ 2
- •ASA class ≤ 3
- •adequate knowledge of the Dutch or French language
- •informed consent
排除标准
- •recurrent brain tumor
- •multiple brain tumor localizations
- •earlier skull radiotherapy
- •earlier chemotherapy for GBM
- •Chronic Kidney Disease or other renal function disorder
- •known MR-contrast allergy
研究组 & 干预措施
Conventional Neuronavigation
Standard form of neuronavigation: based on preoperative MRI without intraoperative correction for brain shift
干预措施: Stealth Station (Device)
Intraoperative MRI
Standard neuronavigation plus intraoperative MRI to correct for brain shift
干预措施: PoleStar N20 (Device)
结局指标
主要结局
Difference in Residual tumor volume
时间窗: <72h after surgery
次要结局
- Complications, Clinical Performance, and Quality of Life(3 months after surgery)
- Survival(2 years after surgery)