This is a prospective, multicenter, single-arm, pilot clinical investigation, aimed at evaluating the safety and preliminary efficacy of the GlioHook implant in patients with high-grade glioma undergoing surgical resection followed by standard of care (SoC) treatment.
GlioHook is a sterile medical device designed to be implanted after tumour resection surgery in suspected high grade glioma patients, covering the entire surface of the tumour resection margins, decreasing infiltration and focalizing the disease, while improving the effects of radiotherapy. Once implanted, GlioHook exerts a dual mechanism that combines tumour cell focalization and radiosensitization.
Willing and able to provide written informed consent prior to the performance of any study-specific procedures.
Age ≥18 and <70 years at the time of consent.
Suspected newly diagnosed unifocal high-grade glioma, as suggested by preoperative MRI imaging.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Life expectancy <3 months, as estimated by the investigator.
Surgical resection cannot be assured or is considered not feasible or unsafe based on preoperative assessment.
Tumor located in the posterior fossa or involving critical subcortical structures (e.g., midbrain, brainstem, ventricles, or basal ganglia), where safe surgical resection cannot be achieved.
Presence of multifocal, bilateral, or recurrent tumor, or prior diagnosis of glioblastoma or other intracranial malignancy.
Batea Oncology
Lead sponsor
Apices Soluciones S.L.
Collaborator