Feasibility of ONCOhabitats for Surgical and Treatment Planning in IDH-Wildtype Glioblastoma (SINUE)

Condition(s) studied

Investigational drug(s) / intervention(s)

The ONCOhabitats software for MRI-based habitat segmentation: 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.

Study 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

Primary outcome measure(s)

• Association of ONCOhabitats-Derived Vascular Biomarkers in the IPE Region With Overall Survival — Imaging biomarkers at surgery (baseline); overall survival followed for up to 24 months post-surgery
  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.

Trial sites (5)

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