Clinical trial · Observational
Connectome-guided Onco-functional Resection With Tractography-Extended Neuronavigation in Brain Tumor Surgery
Connectome-guided Onco-functional Resection With Tractography-Extended Neuronavigation in Brain Tumor Surgery Involving Eloquent Regions: a Prospective Single-centre Cohort Study Integrating Advanced Diffusion MRI Into Clinical Neuronavigation for Gliomas and Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Brain tumor surgery in so-called "eloquent" brain areas aims to remove as much tumor as possible while preserving neurological functions. Standard surgical planning typically focuses on discrete, anatomically defined cortical regions. However, modern neuroscience demonstrates that most brain functions arise from distributed networks of interconnected areas rather than isolated spots - a concept that standard navigation tools do not fully capture. The CORTEX study evaluates a surgical workflow - termed "connectome-guided network-based navigation" - in which advanced diffusion MRI processing is used to reconstruct patient-specific maps of white matter pathways and large-scale brain networks. These maps are imported into a clinical neuronavigation system to guide preoperative planning and intraoperative decision-making for patients with gliomas or brain metastases in eloquent regions. The primary aims are to determine how often network-based information leads to meaningful changes in surgical strategy compared with conventional anatomy-based planning, and to assess early neurological outcomes. Secondary objectives include characterizing the extent of tumor removal, the proximity of the resection to critical white matter tracts, and the feasibility of implementing this pipeline in a high-volume clinical setting.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Connectivity | — | UNRESOLVED | — |
| Brain Metastasases | — | UNRESOLVED | — |
| Brain (Nervous System) Cancers | — | UNRESOLVED | — |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Advanced diffusion MRI tractography and connectome pipeline | Diagnostic Test | — | UNRESOLVED |
| Connectome-guided network-based neuronavigation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- CORTEx cohort
- description
- Consecutive patients undergoing resection of supratentorial gliomas or brain metastases in eloquent or adjacent regions, enrolled in the CORTEX study and treated with integration of advanced diffusion MRI tractography and connectome-based network overlays into the clinical neuronavigation workflow.
- interventionNames
- Procedure: Connectome-guided network-based neuronavigation
- Diagnostic Test: Advanced diffusion MRI tractography and connectome pipeline
Primary outcomes (2)
- measure
- Rate of Major Change in Surgical Plan
- timeFrame
- Intraoperative (day of surgery)
- description
- Proportion of surgical procedures in which integration of network-based tractography information results in a major modification of the initial anatomy-centered surgical plan, defined as a change in the surgical corridor, the planned extent of resection, or the operative indication. Assessed by the operating neurosurgeon at the time of surgical planning.
- measure
- Incidence of major neurological deficit at 3-month follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Indication for supratentorial brain tumor surgery (glioma or metastasis) * Lesion located within or adjacent to eloquent cortical or subcortical regions (motor, language, visual, or higher-order associative networks, as defined by clinical and neuroimaging criteria) * Availability of standardized preoperative and early postoperative brain MRI (including high-direction diffusion tensor imaging, ≥64 directions) * Consistent postoperative clinical follow-up planned at the treating centre * Provision of informed consent for use of anonymized clinical and imaging data Exclusion Criteria: * Inability to undergo pre- or postoperative MRI * Significant comorbidities precluding surgery * Incomplete imaging or clinical data * Purely infratentorial lesions or non-tumoral pathologies
References
Publications (0)
Data not yet available