FUN: Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations

Sponsor

Sklifosovsky Institute of Emergency Care (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05484219

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Tumor, Brain Arteriovenous Malformations Cavernoma	Device: Functional navigation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations: a Prospective, Single Arm Clinical Trial

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2027

Anticipated Study Completion Date :

Aug 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgery Image-guided resection of brain tumors and vascular malformations	Device: Functional navigation Surgeon removes brain tumor or vascular malformation and assesses location of motor areas with functional navigation and intraoperative neuromonitoring

Arm

Intervention/Treatment

Experimental: Surgery

Image-guided resection of brain tumors and vascular malformations

Device: Functional navigation

Surgeon removes brain tumor or vascular malformation and assesses location of motor areas with functional navigation and intraoperative neuromonitoring

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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 scores) [Within 10 days after surgery]
Motor function after surgery in Medical Research Council scale
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
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
Duration of direct cortical and subcortical mapping (in minutes) [Intraoperatively]
How long did it take to perform direct cortical and subcortical mapping
Extent of resection (in percents) [Within 48 hours after surgery]
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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