Actively Recruiting
Led by Juan M Garcia-Gomez · Updated on 2025-08-08
140
Participants Needed
5
Research Sites
N/A
Total Duration
J
Juan M Garcia-Gomez
Lead Sponsor
H
Hospital Clínico Universitario de Valencia
Collaborating Sponsor
Researchers are evaluating ONCOhabitats, an advanced MRI-based software, to support the clinical management of adults with IDH-wildtype glioblastoma, a type of high-grade brain tumor. This observational study aims to determine if imaging biomarkers from pre-surgical MRI scans can predict overall survival and help guide treatment decisions, including responses to temozolomide chemotherapy and immunotherapy. The study focuses on identifying vascular and molecular features within tumor-infiltrated brain regions that relate to patient prognosis. Participants will undergo preoperative MRI scans processed by ONCOhabitats, which segments the tumor into four biological habitats: HAT, LAT, IPE, and VPE. During surgical tumor removal, tissue samples will be collected from these habitats when feasible. Researchers will analyze imaging biomarkers such as relative cerebral blood volume and correlate these with molecular markers like MGMT promoter methylation and gene expression profiles related to immunosuppression. Throughout the study, clinical and survival outcomes will be monitored for up to 24 months after surgery. Participants will provide informed consent and undergo complete preoperative MRI protocols. Researchers will assess the association between imaging and molecular data with patient prognosis, aiming to improve personalized treatment planning and better characterize glioblastoma biology.
CONDITIONS
Feasibility of ONCOhabitats for Surgical and Treatment Planning in IDH-Wildtype Glioblastoma (SINUE)
You may qualify if you...
You will not qualify if you...
Withdrawal criteria:
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week before surgery
Participants undergo a pre-surgical MRI study which is processed using the ONCOhabitats software to support surgical and therapeutic planning.
1 visit (in-person) for MRI study
Duration - Surgery day and hospital stay as per routine care
Participants undergo surgical resection of the glioblastoma tumor with tissue samples collected during surgery for biomarker analysis.
1 surgical visit and immediate post-operative care
Duration - Up to 24 months post-surgery
Participants are followed clinically for up to 24 months to assess overall survival and other outcomes related to imaging and molecular biomarkers.
Regular follow-up visits as per clinical care for up to 24 months
Total: 5 locations
1
Hospital General Universitario Dr. Balmis
Alicante, Spain
Actively Recruiting
2
Hopsital Universitari Vall d'Hebron
Barcelona, Spain
Actively Recruiting
3
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Actively Recruiting
4
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Actively Recruiting
5
Hospital Clínic i Universitari de València
Valencia, Spain
Actively Recruiting
J
Juan Miguel García Gómez, PhD, Full Professor
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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