Feasibility of ONCOhabitats for Surgical and Treatment Planning in IDH-Wildtype Glioblastoma (SINUE)
NCT07111195
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.
Eligibility
Inclusion Criteria: * Adults (≥18 years old) at the time of diagnosis * Radiological diagnosis of high-grade glioma * Candidates for surgical resection * Availability of complete preoperative MRI studies, including: * T1-weighted MRI (pre- and post-gadolinium) * T2-weighted MRI * FLAIR (Fluid-Attenuated Inversion Recovery) * T2\*-weighted DSC perfusion MRI * Signed informed consent to participate in the clinical study Exclusion Criteria: * Patients who do not provide informed consent * Patients deemed inoperable Withdrawal criteria: * MRI data that cannot be processed using ONCOhabitats * Patient withdraws informed consent at any time
Conditions2
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NCT07111195