Connectome-guided Onco-functional Resection With Tractography-Extended Neuronavigation in Brain Tumor Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorARNAS Civico Di Cristina Benfratelli Hospital

About this trial

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

Qualifiers

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

Disqualifiers

Inability to undergo pre- or postoperative MRI

Significant comorbidities precluding surgery

Incomplete imaging or clinical data

Purely infratentorial lesions or non-tumoral pathologies

Trial design

Treatments tested in this trial

  • Connectome-guided network-based neuronavigation
  • Advanced diffusion MRI tractography and connectome pipeline

Treatment groups

400 Participants
are divided into 1 treatment group