Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations (FUN)

April 16, 2024 updated by: Alexander Dmitriev, Sklifosovsky Institute of Emergency Care

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 129090
        • Recruiting
        • Sklifosovsky Institute of Emergency Care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of functional navigation (in millimeters)
Time Frame: 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
Intraoperatively
Accuracy of location of cortical hand/leg motor area, built according to tractography (in millimeters)
Time Frame: 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
Intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral complications
Time Frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Which cerebral complications arose after surgery
From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Constancy of location of cortical hand/leg motor area in fMRI/TMS in relation to precentral gyrus (in millimeters)
Time Frame: 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
Within 2 days before surgery
Factors, violating precision of fMRI/TMS/tractography
Time Frame: 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
Within 2 days before surgery
Motor function (in grades)
Time Frame: Within 10 days after surgery
Motor function is assessed in Medical Research Council scale
Within 10 days after surgery
Distance to stop resection border (in millimeters)
Time Frame: 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
Intraoperatively
Safe resection distance in functional navigation (in millimeters)
Time Frame: 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
Within 10 days after surgery
Duration of direct cortical and subcortical mapping (in minutes)
Time Frame: Intraoperatively
How long did it take to perform direct cortical and subcortical mapping
Intraoperatively
Extent of resection (in percents)
Time Frame: Within 48 hours after surgery
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Within 48 hours after surgery
Karnofsky performance status (in percents)
Time Frame: Within 10 days after surgery
Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale
Within 10 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sklifosovsky Institute of Emergency Care

Investigators

  • Principal Investigator: Alexander Dmitriev, MD, Sklifosovsky Institute of Emergency Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

July 29, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9f

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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