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

NCT07111195 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2025-08-08

No results posted yet for this 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.

Conditions

  • Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Hospital Clínico Universitario de Valencia

    collaborator OTHER

  • Hospital Universitario de Canarias

    collaborator OTHER

  • Hospital General Universitario de Alicante

    collaborator OTHER

  • Hospital Universitario Virgen de la Arrixaca

    collaborator OTHER

  • Hospital Vall d'Hebron

    collaborator OTHER

  • Juan M Garcia-Gomez

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-16
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07111195 on ClinicalTrials.gov