search
Back to results

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

Primary Purpose

Tumor, Brain, Arteriovenous Malformations, Cavernoma

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Functional navigation
Sponsored by
Sklifosovsky Institute of Emergency Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tumor, Brain focused on measuring brain tumor, arteriovenous malformation, cavernoma, cavernous malformation, functional navigation

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sklifosovsky Institute of Emergency CareRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgery

Arm Description

Image-guided resection of brain tumors and vascular malformations

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Constancy of location of cortical hand/leg motor area in fMRI/TMS in relation to precentral gyrus (in millimeters)
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
Which factors lead to disappearing, thinning and dislocation of cortical hand/leg motor areas and corticospinal tract in fMRI/TMS/tractography
Motor function (in grades)
Motor function is assessed in Medical Research Council scale
Distance to stop resection border (in millimeters)
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)
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)
How long did it take to perform direct cortical and subcortical mapping
Extent of resection (in percents)
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Karnofsky performance status (in percents)
Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale
Cerebral complications
Which cerebral complications arose after surgery

Full Information

First Posted
July 29, 2022
Last Updated
December 12, 2022
Sponsor
Sklifosovsky Institute of Emergency Care
search

1. Study Identification

Unique Protocol Identification Number
NCT05484219
Brief Title
Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations
Acronym
FUN
Official Title
Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations: a Prospective, Single Arm Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sklifosovsky Institute of Emergency Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor, Brain, Arteriovenous Malformations, Cavernoma
Keywords
brain tumor, arteriovenous malformation, cavernoma, cavernous malformation, functional navigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Experimental
Arm Description
Image-guided resection of brain tumors and vascular malformations
Intervention Type
Device
Intervention Name(s)
Functional navigation
Intervention Description
Surgeon removes brain tumor or vascular malformation and assesses location of motor areas with functional navigation and intraoperative neuromonitoring
Primary Outcome Measure Information:
Title
Accuracy of functional navigation (in millimeters)
Description
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
Time Frame
Intraoperatively
Title
Accuracy of location of cortical hand/leg motor area, built according to tractography (in millimeters)
Description
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
Time Frame
Intraoperatively
Secondary Outcome Measure Information:
Title
Constancy of location of cortical hand/leg motor area in fMRI/TMS in relation to precentral gyrus (in millimeters)
Description
Maximal distance from the most remote margin of cortical hand/leg motor area in fMRI/TMS to the nearest margin of precentral gyrus
Time Frame
Within 2 days before surgery
Title
Factors, violating precision of fMRI/TMS/tractography
Description
Which factors lead to disappearing, thinning and dislocation of cortical hand/leg motor areas and corticospinal tract in fMRI/TMS/tractography
Time Frame
Within 2 days before surgery
Title
Motor function (in grades)
Description
Motor function is assessed in Medical Research Council scale
Time Frame
Within 10 days after surgery
Title
Distance to stop resection border (in millimeters)
Description
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
Time Frame
Intraoperatively
Title
Safe resection distance in functional navigation (in millimeters)
Description
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
Time Frame
Within 10 days after surgery
Title
Duration of direct cortical and subcortical mapping (in minutes)
Description
How long did it take to perform direct cortical and subcortical mapping
Time Frame
Intraoperatively
Title
Extent of resection (in percents)
Description
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Time Frame
Within 48 hours after surgery
Title
Karnofsky performance status (in percents)
Description
Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale
Time Frame
Within 10 days after surgery
Title
Cerebral complications
Description
Which cerebral complications arose after surgery
Time Frame
From admission to intensive care unit after surgery till hospital discharge, up to 365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Dmitriev, MD
Phone
+7 (916) 423-54-08
Email
dmitriev@neurosklif.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Dmitriev, MD
Organizational Affiliation
Sklifosovsky Institute of Emergency Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sklifosovsky Institute of Emergency Care
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Dmitriev, MD
Phone
+7 (916) 423-54-08
Email
dmitriev@neurosklif.ru

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations

We'll reach out to this number within 24 hrs