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临床试验/NCT01394692
NCT01394692已完成不适用

Resection Control of Primary Brain Tumours Using a Low-Field Intraoperative MRI

Goethe University2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2007年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
2
主要终点
Extent of Resection

研究概览

简要总结

Excision to the maximum possible extent marks the first step of glioma surgery. Depending on tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre studies have shown that the presence of residual tumour according to MRI-criteria is a prognostic factor in this incurable condition.

In order to improve the extent of resection, several methods, in particular intraoperative imaging techniques, have become available to demonstrate already during surgery whether the goal of surgery has been achieved. The intraoperative MRI devices currently available differ in their magnetic field strengths and image resolution, but also in their amount of interference with the surgical workflow.

Prospective, high-class evidence data to promote the use of intraoperative MRI in glioma surgery are lacking. To assess whether the rate of radiologically complete tumour resections can be improved by using intraoperative MRI-guidance, we designed this prospective, randomized trial. We hypothesized that the extent of resection that can be achieved using an intraoperative MRI is greater than that of conventional microsurgical tumor resection.

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

入选标准

  • known or suspected contrast-enhancing glioma (primary and recurrent)
  • location of the tumor permits intended gross-total resection

排除标准

  • tumor location prohibits or questions gross-total resection
  • contraindications to undergo MRI examinations

结局指标

主要结局

Extent of Resection

时间窗: 72 hours

Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved

次要结局

  • Progression-free Survival(6 months)
  • Volumetric Assessment(72 hours)
  • Neurological Deficit(7 days)

研究者

发起方
Goethe University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christian Senft

Neurosurgeon

Goethe University

研究点 (2)

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