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Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations

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

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05484219
Acronym
FUN
Enrollment
50
Registered
2022-08-02
Start date
2022-09-01
Completion date
2027-08-31
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Malformations, Cavernoma, Tumor, Brain

Keywords

brain tumor, arteriovenous malformation, cavernoma, cavernous malformation, functional navigation

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.

Interventions

DEVICEFunctional navigation

Surgeon removes brain tumor or vascular malformation and assesses location of motor areas with functional navigation and intraoperative neuromonitoring

Sponsors

Sklifosovsky Institute of Emergency Care
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of functional navigation (in millimeters)IntraoperativelyMaximal 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)IntraoperativelyMaximal 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

MeasureTime frameDescription
Motor function (in grades)Within 10 days after surgeryMotor function is assessed in Medical Research Council scale
Distance to stop resection border (in millimeters)IntraoperativelyMinimal 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)Within 10 days after surgeryThis 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
Constancy of location of cortical hand/leg motor area in fMRI/TMS in relation to precentral gyrus (in millimeters)Within 2 days before surgeryMaximal distance from the most remote margin of cortical hand/leg motor area in fMRI/TMS to the nearest margin of precentral gyrus
Extent of resection (in percents)Within 48 hours after surgeryExtent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Karnofsky performance status (in percents)Within 10 days after surgeryAssessment of patients' possibilities to self-service in Karnofsky Performance Status scale
Cerebral complicationsFrom admission to intensive care unit after surgery till hospital discharge, up to 365 daysWhich cerebral complications arose after surgery
Duration of direct cortical and subcortical mapping (in minutes)IntraoperativelyHow long did it take to perform direct cortical and subcortical mapping
Factors, violating precision of fMRI/TMS/tractographyWithin 2 days before surgeryWhich factors lead to disappearing, thinning and dislocation of cortical hand/leg motor areas and corticospinal tract in fMRI/TMS/tractography

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026