Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations
- Conditions
- Arteriovenous MalformationsTumor, BrainCavernoma
- Interventions
- Device: Functional navigation
- Registration Number
- NCT05484219
- Lead Sponsor
- Sklifosovsky Institute of Emergency Care
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Surgery Functional navigation Image-guided resection of brain tumors and vascular malformations
- Primary Outcome Measures
Name Time Method Accuracy of location of cortical hand/leg motor area, built according to tractography (in millimeters) 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) 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
- Secondary Outcome Measures
Name Time Method Factors, violating precision of fMRI/TMS/tractography Within 2 days before surgery Which factors lead to disappearing, thinning and dislocation of cortical hand/leg motor areas and corticospinal tract in fMRI/TMS/tractography
Motor function (in grades) Within 10 days after surgery Motor function is assessed in Medical Research Council scale
Safe resection distance in functional navigation (in millimeters) Within 10 days after surgery This outcome is only measured in patients with no deterioration of motor function after surgery. Safe resection distance = accuracy of functional navigation + distance to stop resection border
Cerebral complications From admission to intensive care unit after surgery till hospital discharge, up to 365 days Which cerebral complications arose after surgery
Constancy of location of cortical hand/leg motor area in fMRI/TMS in relation to precentral gyrus (in millimeters) Within 2 days before surgery Maximal distance from the most remote margin of cortical hand/leg motor area in fMRI/TMS to the nearest margin of precentral gyrus
Distance to stop resection border (in millimeters) Intraoperatively Minimal distance from the nearest margin of cortical hand/leg motor area or corticospinal tract to the nearest border of resection of tumor/vascular malformation
Extent of resection (in percents) Within 48 hours after surgery Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Duration of direct cortical and subcortical mapping (in minutes) Intraoperatively How long did it take to perform direct cortical and subcortical mapping
Karnofsky performance status (in percents) Within 10 days after surgery Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale
Trial Locations
- Locations (1)
Sklifosovsky Institute of Emergency Care
🇷🇺Moscow, Russian Federation