Feasibility of ONCOhabitats for Surgical and Treatment Planning in IDH-Wildtype Glioblastoma (SINUE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJuan M Garcia-Gomez
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
This trial does not accept healthy volunteersQualifiers
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 population
Adult patients (≥18 years old) with a radiological diagnosis of IDH-wildtype glioblastoma who are candidates for surgical resection. All participants must have a complete preoperative MRI study, including advanced perfusion sequences, and must provide written informed consent.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
The ONCOhabitats software for MRI-based habitat segmentation
DeviceONCOhabitats 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.
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: Patients with IDH-wildtype Glioblastoma1 intervention
Trial outcomes
Primary outcomes
1
Association of ONCOhabitats-Derived Vascular Biomarkers in the IPE Region With Overall Survival
Imaging biomarkers-including relative cerebral blood volume (rCBV), volume (cm³), and radiomic vascular heterogeneity metrics-will be extracted from the peritumoral infiltrated edema (IPE) habitat using the ONCOhabitats platform on preoperative MRI. These biomarkers will be quantitatively assessed for their association with overall survival. Overall survival is defined as the time from surgical resection to death from any cause, with a follow-up of up to 24 months. Statistical analysis will include Kaplan-Meier survival estimation and Cox proportional hazards regression models.
Time frame
Imaging biomarkers at surgery (baseline); overall survival followed for up to 24 months post-surgerySecondary outcomes
1
Gene Expression Profiles in the IPE Region Associated With Poor Response to Immunotherapy in IDH-Wildtype Glioblastoma
Gene expression analysis will be performed on tissue samples obtained from the peritumoral infiltrated edema (IPE) region during surgical resection. RNA sequencing (RNA-seq) or targeted transcriptomic panels will be used to identify differential expression of immunosuppressive and immune-regulatory genes (e.g., PD-L1, CTLA-4, TGF-β, IDO1) in patients with IDH-wildtype glioblastoma. These molecular profiles will be correlated with clinical response to immunotherapy, as defined by progression-free survival (PFS) and overall survival (OS),
Time frame
Tissue samples collected at surgery; clinical follow-up for up to 24 months2
Histopathological Features in Tumor (HAT, LAT) and Edema (IPE, VPE) Habitats Defined by ONCOhabitats in IDH-Wildtype Glioblastoma
Histopathological analysis will be conducted on tissue samples obtained from four MRI-derived habitats segmented using the ONCOhabitats software platform: * HAT (High Angiogenic Tumor) and LAT (Low Angiogenic Tumor), corresponding to tumor regions * IPE (Infiltrated Peritumoral Edema) and VPE (Vasogenic Peritumoral Edema), corresponding to peritumoral edema regions Tissue sections will be evaluated using hematoxylin and eosin (H\&E) staining and immunohistochemistry to characterize features such as cellularity, necrosis, microvascular proliferation, immune cell infiltration, and other relevant histopathological traits. The aim is to describe and compare the biological composition of tumor versus edema habitats.
Time frame
Tissue samples collected at the time of surgical resection3
Levels of Immunosuppressive Gene Expression in MRI-Derived Habitats (IPE, HAT, VPE)
Tissue samples will be collected from three MRI-derived habitats defined by the ONCOhabitats platform in patients with IDH-wildtype glioblastoma: * IPE (Infiltrated Peritumoral Edema) * HAT (High Angiogenic Tumor) * VPE (Vasogenic Peritumoral Edema) Immunohistochemical and transcriptomic analyses will be performed to quantify the expression of immunosuppressive markers, including but not limited to PD-L1, CTLA-4, TGF-β, and IDO1. The level of immunosuppressive activity in each habitat will be characterized to explore spatial heterogeneity in the tumor microenvironment.
Time frame
Tissue samples collected at the time of surgical resection4
Association Between Perfusion Imaging Biomarkers and Molecular Markers in IDH-Wildtype Glioblastoma
Quantitative perfusion biomarkers-such as relative cerebral blood volume (rCBV), cerebral blood flow (CBF), and Ktrans-will be obtained from preoperative MRI processed with the ONCOhabitats platform. These imaging-derived parameters will be correlated with molecular markers obtained from tumor and edema tissue samples, including MGMT promoter methylation, IDH mutation status, and expression of immune-related genes (e.g., PD-L1, CTLA-4). The aim is to explore associations between vascular imaging features and the underlying molecular profile of IDH-wildtype glioblastoma.
Time frame
MRI performed preoperatively; molecular analysis from tissue samples collected during surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov