RecruitingNCT07111195

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

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


Sponsor

Juan M Garcia-Gomez

Enrollment

140 participants

Start Date

Jul 16, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized software system called ONCOhabitats that uses advanced MRI scans to map different biological zones within a high-grade brain tumor. The goal is to see whether this tool helps surgeons and oncologists better plan surgery and treatment for IDH-wildtype gliomas (an aggressive type of brain cancer). **You may be eligible if...** - You are 18 years or older - Imaging has suggested you have a high-grade glioma (aggressive brain tumor) - You are a candidate for surgical removal of the tumor - You have had a full set of required brain MRI scans before surgery (including standard, contrast, FLAIR, and perfusion sequences) - You are willing to provide informed consent **You may NOT be eligible if...** - You are not able or willing to provide informed consent - Your doctors determine you are not suitable for surgery - Your MRI images cannot be processed by the ONCOhabitats software Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEThe 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.


Locations(5)

Hospital General Universitario Dr. Balmis

Alicante, Spain

Hopsital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Hospital Clínic i Universitari de València

Valencia, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07111195


Related Trials