Feasibility Evaluation of ONCOhabitats for Supporting Surgical and Therapeutic Planning in Patients With IDH-Wildtype Glioblastoma (SINUE)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Hopsital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Clínico Universitario Virgen de la Arrixaca
RECRUITING
Murcia
Hospital Universitario de Canarias
RECRUITING
Santa Cruz De Tenerife
Hospital Clínic i Universitari de València
RECRUITING
Valencia
Contact Information
Primary
Juan Miguel García Gómez, PhD, Full Professor
juanmig@upv.es
+34 963877069
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2026-09
Participants
Target number of participants: 140
Treatments
Patients with IDH-wildtype Glioblastoma
Patients with IDH-wildtype glioblastoma who have undergone a pre-surgical MRI study
Sponsors
Collaborators: Hospital Vall d'Hebron, Hospital General Universitario de Alicante, Hospital Clínico Universitario de Valencia, Hospital Universitario Virgen de la Arrixaca, Hospital Universitario de Canarias
Leads: Juan M Garcia-Gomez

This content was sourced from clinicaltrials.gov