Feasibility of ONCOhabitats for Surgical and Treatment Planning in IDH-Wildtype Glioblastoma (SINUE)
Feasibility Evaluation of ONCOhabitats for Supporting Surgical and Therapeutic Planning in Patients With IDH-Wildtype Glioblastoma (SINUE)
Juan M Garcia-Gomez
140 participants
Jul 16, 2024
OBSERVATIONAL
Conditions
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 Criteria9
- 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 Criteria5
- 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
Interventions
ONCOhabitats is an MRI-based software platform designed to segment IDH-wildtype glioblastomas into four biologically distinct habitats (HAT, LAT, IPE, and VPE) based on vascular heterogeneity. In this study, the software is applied preoperatively to generate imaging biomarkers that guide surgical sampling and are assessed for their ability to predict overall survival and stratify patients accordingly. The intervention includes advanced perfusion imaging processing using the HTS methodology, non-invasive tumor characterization, and integration with molecular and histopathological data.
Locations(5)
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NCT07111195