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

Juan M Garcia-Gomez

Status: Enrolling

Conditions: Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype

Treatments: Device: The ONCOhabitats software for MRI-based habitat segmentation

Study type: Observational

Funder types: Other

Identifiers

NCT07111195

INNEST/2022/087

Details and patient eligibility

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

140 participants in 1 patient group

Patients with IDH-wildtype Glioblastoma

Description:

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

Treatment:

Device: The ONCOhabitats software for MRI-based habitat segmentation