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NCT07717827
Connectome-guided Onco-functional Resection With Tractography-Extended Neuronavigation in Brain Tumor Surgery
Conditions: Brain (Nervous System) Cancers, Glioma, Brain Metastasases, Brain Connectivity
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 400
Sponsor: ARNAS Civico Di Cristina Benfratelli Hospital
Location: Unit of Neurosurgery - A.R.N.A.S. Civico Di Cristina Benfratelli - 90127, Palermo - Italy Palermo PA
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07717827). StuddyBuddy aggregates publicly available trial information.