Arteriovenous Malformations Clinical Trial
— FUNOfficial title:
Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations: a Prospective, Single Arm Clinical Trial
NCT number | NCT05484219 |
Other study ID # | 9f |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2022 |
Est. completion date | August 31, 2027 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | August 31, 2027 |
Est. primary completion date | August 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Sklifosovsky Institute of Emergency Care | Moscow |
Lead Sponsor | Collaborator |
---|---|
Sklifosovsky Institute of Emergency Care |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Intraoperatively | |
Primary | 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 | Intraoperatively | |
Secondary | 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 | Within 2 days before surgery | |
Secondary | 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 | Within 2 days before surgery | |
Secondary | Motor function (in grades) | Motor function is assessed in Medical Research Council scale | Within 10 days after surgery | |
Secondary | 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 | Intraoperatively | |
Secondary | 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 | Within 10 days after surgery | |
Secondary | Duration of direct cortical and subcortical mapping (in minutes) | How long did it take to perform direct cortical and subcortical mapping | Intraoperatively | |
Secondary | Extent of resection (in percents) | Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100 | Within 48 hours after surgery | |
Secondary | Karnofsky performance status (in percents) | Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale | Within 10 days after surgery | |
Secondary | Cerebral complications | Which cerebral complications arose after surgery | From admission to intensive care unit after surgery till hospital discharge, up to 365 days |
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