Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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