NCT07111195Recruiting
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)
Source: ClinicalTrials.gov · Last updated 8 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 140 (estimated)
- First submitted
- 24 Jul 2025
- Start date
- 16 Jul 2024
- Primary completion date
- Sept 2026
- Lead sponsor
- Juan M Garcia-Gomez
- Diseases
- Glioblastoma
- NCT number
- NCT07111195
What you commit to
- Study type: Observational
- Planned participants: 140
- From 16 Jul 2024 to the primary completion date, Sept 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hopsital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clínico Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Hospital Universitario de Canarias Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Recruiting |
| Hospital Clínic i Universitari de València Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.