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

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

140 Participants
are divided into 1 treatment group

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