About this trial
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 criteria
Qualifiers
Adults (≥18 years old) at the time of diagnosis
Radiological diagnosis of high-grade glioma
Candidates for surgical resection
T1-weighted MRI (pre- and post-gadolinium)
Disqualifiers
Patients who do not provide informed consent
Patients deemed inoperable
MRI data that cannot be processed using ONCOhabitats
Patient withdraws informed consent at any time
Trial design
Treatments tested in this trial
- The ONCOhabitats software for MRI-based habitat segmentation
Treatment groups
Sponsors and collaborators
Juan M Garcia-Gomez
Lead sponsor
Universitat Politècnica de València
Sponsor institution
Hospital Clínico Universitario de Valencia
Collaborator
Hospital Universitario de Canarias
Collaborator
Hospital General Universitario de Alicante
Collaborator
Hospital Universitario Virgen de la Arrixaca
Collaborator
Hospital Vall d'Hebron
Collaborator