Role of 3-D Navigable Ultrasound in Resection of Intra-axial Brain Tumors - A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Percentage of patients where Gross total resection (GTR) achieved
研究概览
简要总结
Phase 3 randomized open labeled trials will evaluate the 3 D navigable ultrasound (SonoWand) in improving the extent of resection in intra-axial brain tumors. All patients will undergo resective surgery. In the experimental arm, a navigable 3 D ultrasound will be used. In the standard arm, only navigation will be used. This study will help in assessing the usefulness sononavigation in improving radicality of resection in malignant gliomas and also to access the accuracy of SonoWand in predicting residue (histopathological correlation).
详细描述
Routine presurgical evaluation of all patients will be conducted. The preoperative use of steroids, antiepileptics and other medications would be as per standard procedure and would be documented. In addition detailed MRI evaluation will be performed (including contrast enhanced MRI study, diffusion MRI, perfusion MR, MR spectroscopy, dynamic-contrast-enhanced MRI for permeability studies, as well as functional MRI, and tractography if required) not more than 1 week prior to the date of surgery.
Navigation specific MR sequences would be performed in all patients (both arms).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •All radiologically-suspected, previously untreated, supratentorial malignant gliomas being considered for debulking surgery.
- •Adults (above 18 years)
- •Eligible for surgical therapy (craniotomy not stereotactic biopsy )
- •Resectability : A lesion would be considered "resectable" if the surgeons feel that all the radiologically imaged lesion can be removed (with reasonable certainty). Only deemed resectable lesions will be included
排除标准
- •Unfit for GA
- •Unwilling for the study
- •Unresectable lesion
研究组 & 干预措施
Navigation only group
Sonowand system will be used for navigation control arm as well as sononavigation experimental arm.Navigation will be used to plan the craniotomy and throughout the procedure as desired by the operating surgeon. At no point of time however will the Ultrasound be used.
干预措施: Navigation (Procedure)
SonoRCT Test group
Surgery to resect the tumor with the aid of sononavigation. In addition to the navigation function, the Ultrasound will be available at all times. This study will help in assessing the usefulness sononavigation in improving radicality of resection in malignant gliomas and also to access the accuracy of SonoWand in predicting residue.
干预措施: Sonowand (Device)
结局指标
主要结局
Percentage of patients where Gross total resection (GTR) achieved
时间窗: Post operative within 72 hrs.
Measure: Volumetric MRI - residual tumor (in cc)
次要结局
- Accuracy of US(Post operative within 72 hrours)
研究者
Dr Aliasgar V Moiyadi
Prof and Neurosurgeon
Tata Memorial Hospital