[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648036":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":36,"responsibleParty":62,"collaborators":10,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":10,"enrollmentInfo":75,"targetDuration":10,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"ARNAS Civico Di Cristina Benfratelli Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CORTEx cohort",null,"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.",[13,14],"Procedure: Connectome-guided network-based neuronavigation","Diagnostic Test: Advanced diffusion MRI tractography and connectome pipeline",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"PROCEDURE","Connectome-guided network-based neuronavigation","Integration of patient-specific white matter tractography and large-scale brain network overlays, derived from advanced diffusion MRI processing, into a clinical neuronavigation platform for preoperative planning and intraoperative guidance of brain tumor resection in eloquent regions",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DIAGNOSTIC_TEST","Advanced diffusion MRI tractography and connectome pipeline","Open-source multi-tissue constrained spherical deconvolution tractography, cortical parcellation and segmentation, diffusion preprocessing and brain connectivity mapping with automated Bash\u002FPython scripting for streamlined and reproducible clinical implementation.",[9],[27],{"name":28,"affiliation":29,"role":30},"Giovanni Tringali, M.D.","Unit of Neurosurgery - A.R.N.A.S. Civico Di Cristina Benfratelli - 90127, Palermo - Italy","PRINCIPAL_INVESTIGATOR",[32],{"name":28,"role":33,"phone":34,"phoneExt":10,"email":35},"CONTACT","+390916661111","giovanni.tringali@arnascivico.it",[37],{"facility":29,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Palermo","PA","90127","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],13.3636,38.1166,{"lat":48,"lon":47},[51,52,53,56,58,60],{"name":28,"role":33,"phone":34,"phoneExt":10,"email":35},{"name":28,"role":30,"phone":10,"phoneExt":10,"email":10},{"name":54,"role":55,"phone":10,"phoneExt":10,"email":10},"Umberto Emanuele Benigno, M.D.","SUB_INVESTIGATOR",{"name":57,"role":55,"phone":10,"phoneExt":10,"email":10},"Lapo Bonosi, M.D.",{"name":59,"role":55,"phone":10,"phoneExt":10,"email":10},"Giuseppe Roberto Giammalva, M.D. PhD",{"name":61,"role":55,"phone":10,"phoneExt":10,"email":10},"Gabriele Costantino, M.D.",{"type":30,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Giovanni Tringali","Dr. Giovanni Tringali","100648036","connectome-guided-onco-functional-resection-with-tractography-extended-neuronavigation-in-brain-tumor-surgery-100648036",false,"NCT07717827","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","CORTEx","Inclusion Criteria:\n\n* Indication for supratentorial brain tumor surgery (glioma or metastasis)\n* 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)\n* Availability of standardized preoperative and early postoperative brain MRI (including high-direction diffusion tensor imaging, ≥64 directions)\n* Consistent postoperative clinical follow-up planned at the treating centre\n* Provision of informed consent for use of anonymized clinical and imaging data\n\nExclusion Criteria:\n\n* Inability to undergo pre- or postoperative MRI\n* Significant comorbidities precluding surgery\n* Incomplete imaging or clinical data\n* Purely infratentorial lesions or non-tumoral pathologies","ALL","18 Years",{"count":76,"type":77},400,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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.\n\nThe 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.",[81,82,83,84],"Brain (Nervous System) Cancers","Glioma","Brain Metastasases","Brain Connectivity",[86,87,88,89,90,91,92,93,94,95,96,97,98,71],"diffusion MRI","tractography","neuronavigation","connectome","eloquent cortex","brain tumor surgery","white matter","glioma","brain metastasis","extent of resection","onco-functional balance","network neuroscience","neural networks","2026-07-16",{"date":101,"type":102},"2026-07-21","ACTUAL",{"date":104,"type":102},"2022-01-01",{"date":106,"type":77},"2027-12",{"name":5,"class":6},1]