NCT07111195 Feasibility of ONCOhabitats for Surgical and Treatment Planning in IDH-Wildtype Glioblastoma (SINUE)
| NCT ID | NCT07111195 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Juan M Garcia-Gomez |
| Condition | Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-07-16 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2024-07-16 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07111195 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07111195 currently recruiting?
Yes, NCT07111195 is actively recruiting participants. Contact the research team at juanmig@upv.es for enrollment information.
Where is the NCT07111195 trial being conducted?
This trial is being conducted at Alicante, Spain, Barcelona, Spain, Murcia, Spain, Santa Cruz de Tenerife, Spain and 1 additional location.
Who is sponsoring the NCT07111195 clinical trial?
NCT07111195 is sponsored by Juan M Garcia-Gomez. The trial plans to enroll 140 participants.
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