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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

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