Actively Recruiting

Age: 18Years +
All Genders
NCT07111195

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

Led by Juan M Garcia-Gomez · Updated on 2025-08-08

140

Participants Needed

5

Research Sites

111 weeks

Total Duration

On this page

Sponsors

J

Juan M Garcia-Gomez

Lead Sponsor

H

Hospital Clínico Universitario de Valencia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 (pre- and post-gadolinium), T2-weighted, FLAIR, and T2*-weighted DSC perfusion MRI
  • Signed informed consent to participate in the clinical study
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Hospital General Universitario Dr. Balmis

Alicante, Spain

Actively Recruiting

2

Hopsital Universitari Vall d'Hebron

Barcelona, Spain

Actively Recruiting

3

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Actively Recruiting

4

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Actively Recruiting

5

Hospital Clínic i Universitari de València

Valencia, Spain

Actively Recruiting

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Research Team

J

Juan Miguel García Gómez, PhD, Full Professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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