ONCOhabitats for surgical and treatment planning in IDH‑wildtype glioblastoma
Feasibility Evaluation of ONCOhabitats for Supporting Surgical and Therapeutic Planning in Patients With IDH-Wildtype Glioblastoma (SINUE)
This project will try ONCOhabitats MRI software to see if its tumor 'habitat' maps can predict outcomes and help adults with IDH‑wildtype glioblastoma who are having surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitat Politècnica de València Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 5 sites (Alicante and 4 other locations) |
| Trial ID | NCT07111195 on ClinicalTrials.gov |
What this trial studies
Researchers will use ONCOhabitats software to analyze preoperative MRI scans and segment IDH‑wildtype glioblastomas into four biological habitats (HAT, LAT, IPE, VPE). The study will collect tissue samples from those habitats when surgically feasible and link imaging biomarkers, including perfusion-derived measures, to overall survival and treatment responses such as temozolomide and immunotherapy. It is an observational study enrolling adults scheduled for tumor resection who have the required MRI sequences, including DSC perfusion. The goal is prospective clinical validation of ONCOhabitats as a decision-support tool for prognosis and treatment planning.
Who should consider this trial
Good fit: Adults (≥18) with radiologic high‑grade glioma consistent with IDH‑wildtype who are candidates for surgical resection, can undergo the required preoperative MRI (including DSC perfusion), and can give informed consent.
Not a fit: Patients who are deemed inoperable, lack the required MRI sequences or quality for processing, or withdraw consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, ONCOhabitats could provide noninvasive maps that help personalize surgical and medical treatment and better predict survival for patients with IDH‑wildtype glioblastoma.
How similar studies have performed: Preliminary research using MRI habitat mapping and perfusion biomarkers has shown promising correlations with tumor biology and prognosis, but prospective clinical validation in IDH‑wildtype glioblastoma remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Alicante and 4 other locations
- Hospital General Universitario Dr. Balmis — Alicante, Spain (Recruiting)
- Hopsital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Clínico Universitario Virgen de la Arrixaca — Murcia, Spain (Recruiting)
- Hospital Universitario de Canarias — Santa Cruz de Tenerife, Spain (Recruiting)
- Hospital Clínic i Universitari de València — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Juan Miguel García Gómez, PhD, Full Professor
- Email: juanmig@upv.es
- Phone: +34 963877069
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.