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

NCT07111195 | Recruiting DMC

• 1 other identifier: INNEST/2022/087
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Glioblastoma; IHD-wildtype; MRI; Biomarkers; Perfussion; Tumor heterogenity; Peritumoral edema; Tumor Infiltration; Machine learning; Medical device validation; Immunosuppression; Overall survival; MGMT status

Outcome Measures

Primary Outcomes (1)

• Association of ONCOhabitats-Derived Vascular Biomarkers in the IPE Region With Overall Survival

  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.

  Imaging biomarkers at surgery (baseline); overall survival followed for up to 24 months post-surgery

Secondary Outcomes (8)

• Gene Expression Profiles in the IPE Region Associated With Poor Response to Immunotherapy in IDH-Wildtype Glioblastoma

  Tissue samples collected at surgery; clinical follow-up for up to 24 months

• Histopathological Features in Tumor (HAT, LAT) and Edema (IPE, VPE) Habitats Defined by ONCOhabitats in IDH-Wildtype Glioblastoma

  Tissue samples collected at the time of surgical resection

• Levels of Immunosuppressive Gene Expression in MRI-Derived Habitats (IPE, HAT, VPE)

  Tissue samples collected at the time of surgical resection

• Association Between Perfusion Imaging Biomarkers and Molecular Markers in IDH-Wildtype Glioblastoma

  MRI performed preoperatively; molecular analysis from tissue samples collected during surgery

• Predictive Value of Combined Imaging, Histopathological, Molecular, and Cellular Biomarkers in IDH-Wildtype Glioblastoma

  Biomarker data collected at surgery; clinical follow-up up to 24 months post-surgery

Study Arms (1)

Patients with IDH-wildtype Glioblastoma

Patients with IDH-wildtype glioblastoma who have undergone a pre-surgical MRI study

Device: The ONCOhabitats software for MRI-based habitat segmentation

Interventions

The ONCOhabitats software for MRI-based habitat segmentation DEVICE

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.

Patients with IDH-wildtype Glioblastoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years old) with a radiological diagnosis of IDH-wildtype glioblastoma who are candidates for surgical resection. All participants must have a complete preoperative MRI study, including advanced perfusion sequences, and must provide written informed consent.

You may qualify if:

• 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 MRI (pre- and post-gadolinium)
• T2-weighted MRI
• FLAIR (Fluid-Attenuated Inversion Recovery)
• T2\*-weighted DSC perfusion MRI
• Signed informed consent to participate in the clinical study

You may not qualify if:

• Patients who do not provide informed consent
• Patients deemed inoperable
• Withdrawal criteria:
• MRI data that cannot be processed using ONCOhabitats
• Patient withdraws informed consent at any time

Sponsors & Collaborators

• Juan M Garcia-Gomez: lead
• 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

Study Sites (5)

Hospital General Universitario Dr. Balmis

Alicante, Spain

RECRUITING

Hopsital Universitari Vall d'Hebron

Barcelona, Spain

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

RECRUITING

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

RECRUITING

Hospital Clínic i Universitari de València

Valencia, Spain

RECRUITING

Related Publications (3)

• Juan-Albarracin J, Fuster-Garcia E, Perez-Girbes A, Aparici-Robles F, Alberich-Bayarri A, Revert-Ventura A, Marti-Bonmati L, Garcia-Gomez JM. Glioblastoma: Vascular Habitats Detected at Preoperative Dynamic Susceptibility-weighted Contrast-enhanced Perfusion MR Imaging Predict Survival. Radiology. 2018 Jun;287(3):944-954. doi: 10.1148/radiol.2017170845. Epub 2018 Jan 19.

  PMID: 29357274 BACKGROUND

• Del Mar Alvarez-Torres M, Juan-Albarracin J, Fuster-Garcia E, Bellvis-Bataller F, Lorente D, Reynes G, Font de Mora J, Aparici-Robles F, Botella C, Munoz-Langa J, Faubel R, Asensio-Cuesta S, Garcia-Ferrando GA, Chelebian E, Auger C, Pineda J, Rovira A, Oleaga L, Molla-Olmos E, Revert AJ, Tshibanda L, Crisi G, Emblem KE, Martin D, Due-Tonnessen P, Meling TR, Filice S, Saez C, Garcia-Gomez JM. Robust association between vascular habitats and patient prognosis in glioblastoma: An international multicenter study. J Magn Reson Imaging. 2020 May;51(5):1478-1486. doi: 10.1002/jmri.26958. Epub 2019 Oct 26.

  PMID: 31654541 BACKGROUND

• Juan-Albarracin J, Fuster-Garcia E, Garcia-Ferrando GA, Garcia-Gomez JM. ONCOhabitats: A system for glioblastoma heterogeneity assessment through MRI. Int J Med Inform. 2019 Aug;128:53-61. doi: 10.1016/j.ijmedinf.2019.05.002. Epub 2019 May 16.

  PMID: 31160012 BACKGROUND

Related Links

• ONCOhabitats website

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Juan Miguel García Gómez, PhD, Full Professor

CONTACT

+34 963877069; juanmig@upv.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 8, 2025
• Study Start: July 16, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-07

Locations

ES (5)