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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07111195
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Juan M Garcia-Gomez
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
Study Website:	View Trial Website

Arms & Interventions

Arms

: Patients with IDH-wildtype Glioblastoma

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

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.

Contact a Trial Team

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