Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations

NCT ID: NCT05484219

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2027-08-31

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.

Conditions

Tumor, Brain; Arteriovenous Malformations; Cavernoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery

Image-guided resection of brain tumors and vascular malformations

Group Type: EXPERIMENTAL

Functional navigation

Intervention Type: DEVICE

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

Interventions

Functional navigation

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sklifosovsky Institute of Emergency Care

OTHER_GOV

Sponsor Role: lead

Responsible Party

Alexander Dmitriev

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Dmitriev, MD

Role: PRINCIPAL_INVESTIGATOR

Sklifosovsky Institute of Emergency Care

Locations

Sklifosovsky Institute of Emergency Care

Moscow, , Russia

Countries

Russia

Other Identifiers

9f

Identifier Type: -

Identifier Source: org_study_id