Overview
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
