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

Recruitingn/aAges 18 Years - anyAllJuan M Garcia-Gomez
NCT07111195 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 (H

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📋 Eligibility rules (as published)
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
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What it tests

  • The ONCOhabitats software for MRI-based habitat segmentation
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Where

5 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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