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Feasibility Evaluation of ONCOhabitats for Supporting Surgical and Therapeutic Planning in Patients With IDH-Wildtype Glioblastoma (SINUE)
The goal of this clinical trial is to validate ONCOhabitats, an advanced imaging software, as a medical device for the clinical management of IDH-wildtype glioblastoma. The study aims to evaluate whether imaging biomarkers derived from pre-surgical MRI using ONCOhabitats can predict overall survival and support clinical decision-making. The primary research questions are: * Can ONCOhabitats identify vascular and molecular characteristics within the peritumoral infiltrated edema (IPE) that are associated with patient prognosis? * Can these imaging biomarkers aid in stratifying patients according to their response to treatment, including temozolomide and immunotherapy? Participants will: * Be adults diagnosed with high-grade glioma who are scheduled for surgical tumor resection * Undergo preoperative MRI processed with ONCOhabitats to segment the tumor into four biological habitats (HAT, LAT, IPE, and VPE) * Provide tissue samples from each habitat when feasible, based on surgical and clinical considerations Researchers will analyze: * Imaging biomarkers (e.g., relative cerebral blood volume, rCBV) * Molecular and histopathological features (e.g., MGMT promoter methylation, gene expression profiles associated with immunosuppression) * Clinical and survival outcomes This study seeks to enhance glioblastoma characterization and support personalized treatment strategies through the clinical validation of a software platform.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hopsital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Hospital Clínic i Universitari de València
Valencia, Spain
Start Date
July 16, 2024
Primary Completion Date
September 1, 2026
Completion Date
September 1, 2026
Last Updated
August 8, 2025
140
ESTIMATED participants
The ONCOhabitats software for MRI-based habitat segmentation
DEVICE
Lead Sponsor
Juan M Garcia-Gomez
Collaborators
Data Source & Attribution
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