Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations

NCT05484219 | Suspended

• 1 other identifier: 9f
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor, Brain; Arteriovenous Malformations; Cavernoma

Keywords

brain tumor; arteriovenous malformation; cavernoma; cavernous malformation; functional navigation

Outcome Measures

Primary Outcomes (2)

• Accuracy of functional navigation (in millimeters)

  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

  Intraoperatively

• Accuracy of location of cortical hand/leg motor area, built according to tractography (in millimeters)

  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

  Intraoperatively

Secondary Outcomes (9)

• Constancy of location of cortical hand/leg motor area in fMRI/TMS in relation to precentral gyrus (in millimeters)

  Within 2 days before surgery

• Factors, violating precision of fMRI/TMS/tractography

  Within 2 days before surgery

• Motor function (in grades)

  Within 10 days after surgery

• Distance to stop resection border (in millimeters)

  Intraoperatively

• Safe resection distance in functional navigation (in millimeters)

  Within 10 days after surgery

Study Arms (1)

Surgery

EXPERIMENTAL

Image-guided resection of brain tumors and vascular malformations

Device: Functional navigation

Interventions

Functional navigation DEVICE

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

Surgery

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sklifosovsky Institute of Emergency Care: lead

Study Sites (1)

Sklifosovsky Institute of Emergency Care

Moscow, 129090, Russia

Location

MeSH Terms

Conditions

Brain Neoplasms; Arteriovenous Malformations; Hemangioma, Capillary

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type

Study Officials

• Alexander Dmitriev, MD

  Sklifosovsky Institute of Emergency Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 2, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)