Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations: a Prospective, Single Arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Accuracy of location of cortical hand/leg motor area, built according to tractography (in millimeters)
研究概览
简要总结
The purpose of the study is to assess accuracy, advantages of functional neuronavigation and calculate safe distance from motor areas to brain tumors and vascular malformations in image-guided surgery.
详细描述
Functional images (functional magnetic resonance imaging (fMRI), transcranial magnetic stimulation (TMS), tractography) loaded in neuronavigation are called functional navigation. It is usually combined with anatomical data and allows to display eloquent brain areas. Currently there are plenty of studies concerning possibilities of it's use. In our research we plan to confirm this data and to supplement them with calculating a safe distance from motor areas to various mass lesions in preoperative scans where neurological deficits is not likely to appear after surgery. In case of success this data can be a foundation for further researches specifying indications for use of intraoperative neuromonitoring and possibility of it's replacement with functional navigation in some cases.
The purpose of the study is to assess accuracy, advantages of functional neuronavigation and calculate safe distance from motor areas to brain tumors and vascular malformations in image-guided surgery. For each patient a surgeon intraoperatively will assess locations of motor cortex and corticospinal tract found with direct cortical and subcortical stimulation and capture them. After surgery he will compare this data with functional preoperative scans and virtual motor centers constructed based on tractography. Influence of various factors on precision of functional navigation will be studied and safe distance between motor brain areas and mass lesion borders will be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •all intracranial tumors
- •arteriovenous malformations
- •cavernous malformations
- •supratentorial localization
- •newly diagnosed
- •age 18-79 years
- •unaltered consciousness
- •error of patient registration in neuronavigation no more than 2 mm
- •possibility to perform "positive mapping" strategy
排除标准
- •contraindications to magnetic resonance imaging or transcranial magnetic stimulation
- •inability to build tractography in neuronavigation
- •predicting of intraoperative brain shift 6 mm and more without possibility to correct it
- •real intraoperative brain shift 6 mm and more without possibility to correct it
- •previously performed brain radiotherapy
- •pregnancy
- •breast feeding
结局指标
主要结局
Accuracy of location of cortical hand/leg motor area, built according to tractography (in millimeters)
时间窗: Intraoperatively
Maximal distance from the most remote margin of cortical hand/leg motor area, built according to tractography and loaded into navigation, to the nearest margin of this area in direct cortical stimulation
Accuracy of functional navigation (in millimeters)
时间窗: Intraoperatively
Maximal distance from the most remote margin of cortical hand/leg motor area or corticospinal tract in the area of corona radiata in functional navigation to the nearest margin of this area/tract in direct cortical/subcortical stimulation
次要结局
- Factors, violating precision of fMRI/TMS/tractography(Within 2 days before surgery)
- Motor function (in grades)(Within 10 days after surgery)
- Safe resection distance in functional navigation (in millimeters)(Within 10 days after surgery)
- Cerebral complications(From admission to intensive care unit after surgery till hospital discharge, up to 365 days)
- Constancy of location of cortical hand/leg motor area in fMRI/TMS in relation to precentral gyrus (in millimeters)(Within 2 days before surgery)
- Distance to stop resection border (in millimeters)(Intraoperatively)
- Extent of resection (in percents)(Within 48 hours after surgery)
- Duration of direct cortical and subcortical mapping (in minutes)(Intraoperatively)
- Karnofsky performance status (in percents)(Within 10 days after surgery)
研究者
Alexander Dmitriev
Principal Investigator
Sklifosovsky Institute of Emergency Care