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

Sklifosovsky Institute of Emergency Care

Status: Enrolling

Conditions: Cavernoma; Arteriovenous Malformations; Tumor, Brain

Treatments: Device: Functional navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT05484219

9f

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Surgery

Experimental group

Description:

Image-guided resection of brain tumors and vascular malformations

Treatment:

Device: Functional navigation