Clinical Research Directory

Feasibility of ONCOhabitats for Surgical and Treatment Planning in IDH-Wildtype Glioblastoma (SINUE)

Sponsor: Juan M Garcia-Gomez

Summary

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.

Official title: Feasibility Evaluation of ONCOhabitats for Supporting Surgical and Therapeutic Planning in Patients With IDH-Wildtype Glioblastoma (SINUE)

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