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Trial Title:
Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations
NCT ID:
NCT05484219
Condition:
Tumor, Brain
Arteriovenous Malformations
Cavernoma
Conditions: Official terms:
Brain Neoplasms
Hemangioma, Cavernous
Arteriovenous Malformations
Vascular Malformations
Congenital Abnormalities
Conditions: Keywords:
brain tumor
arteriovenous malformation
cavernoma
cavernous malformation
functional navigation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Functional navigation
Description:
Surgeon removes brain tumor or vascular malformation and assesses location of motor areas
with functional navigation and intraoperative neuromonitoring
Arm group label:
Surgery
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
79 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sklifosovsky Institute of Emergency Care
Address:
City:
Moscow
Zip:
129090
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Alexander Dmitriev, MD
Phone:
+7 (916) 423-54-08
Email:
dmitriev@neurosklif.ru
Start date:
September 1, 2022
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Sklifosovsky Institute of Emergency Care
Agency class:
Other
Source:
Sklifosovsky Institute of Emergency Care
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05484219