Software Tested on Brain Scans to Plan Surgery for Glioblastoma
Tests imaging software on pre-surgery MRI scans of adults with IDH-wildtype glioblastoma.
Plain-language title generated from the registry record
Registry title: Feasibility of ONCOhabitats for Surgical and Treatment Planning in IDH-Wildtype Glioblastoma (SINUE)
Key facts
- Where
- Alicante, Barcelona, Murcia, Santa Cruz de Tenerife, and Valencia, SpainSee the 5 sites
Where in Spain
- Hospital General Universitario Dr. BalmisAlicante, SpainTaking people
- Hopsital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Clínico Universitario Virgen de la ArrixacaMurcia, SpainTaking people
- Hospital Universitario de CanariasSanta Cruz de Tenerife, SpainTaking people
- Hospital Clínic i Universitari de ValènciaValencia, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Juan M Garcia-Gomez
- Trial code
- NCT07111195
- Record updated
- 8 August 2025
- Original description
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.Read full original descriptionShow less
Feasibility Evaluation of ONCOhabitats for Supporting Surgical and Therapeutic Planning in Patients With IDH-Wildtype Glioblastoma (SINUE)
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.
Inclusion: 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: 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.