Clinical trial · Interventional
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
NCT05484219CI-TRIAL-00089796FUNsuspendedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): technical issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arteriovenous Malformations | — | UNRESOLVED | — |
| Cavernoma | Cavernous Hemangioma | ALIAS | 0.90 |
| Tumor, Brain | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Functional navigation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surgery
- description
- Image-guided resection of brain tumors and vascular malformations
- interventionNames
- Device: Functional navigation
Primary outcomes (2)
- measure
- Accuracy of functional navigation (in millimeters)
- timeFrame
- Intraoperatively
- description
- 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
- measure
- Accuracy of location of cortical hand/leg motor area, built according to tractography (in millimeters)
- timeFrame
- Intraoperatively
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.