Clinical trial NCT05484219: Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations
Official title: Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations: a Prospective, Single Arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Tumor, Brain
Arteriovenous Malformations
Cavernoma
Keywords: brain tumor
arteriovenous malformation
cavernoma
cavernous malformation
functional navigation
Lead sponsor: Sklifosovsky Institute of Emergency Care
Sponsor class: OTHER_GOV
First posted: 2022-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of functional navigation (in millimeters)
timeFrame: Intraoperatively
measure: Accuracy of location of cortical hand/leg motor area, built according to tractography (in millimeters)
timeFrame: Intraoperatively
Secondary outcomes:
measure: Constancy of location of cortical hand/leg motor area in fMRI/TMS in relation to precentral gyrus (in millimeters)
timeFrame: Within 2 days before surgery
measure: Factors, violating precision of fMRI/TMS/tractography
timeFrame: Within 2 days before surgery
measure: Motor function (in grades)
timeFrame: Within 10 days after surgery
measure: Distance to stop resection border (in millimeters)
timeFrame: Intraoperatively
measure: Safe resection distance in functional navigation (in millimeters)
timeFrame: Within 10 days after surgery
measure: Duration of direct cortical and subcortical mapping (in minutes)
timeFrame: Intraoperatively
measure: Extent of resection (in percents)
timeFrame: Within 48 hours after surgery
measure: Karnofsky performance status (in percents)
timeFrame: Within 10 days after surgery
measure: Cerebral complications
timeFrame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sklifosovsky Institute of Emergency Care
Study officials:
affiliation: Sklifosovsky Institute of Emergency Care
name: Alexander Dmitriev, MD
role: PRINCIPAL_INVESTIGATOR
References: