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.
Single group
GlioHook device
DeviceGlioHook 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.
To evaluate the safety of the GlioHook implant, as measured by the occurrence of adverse events related to the GlioHook implant, as well as events involving the need for device removal
Incidence of adverse events directly related to the implant of the device during follow-up, measured following NCI-CTCAE v6.0 guidelines, including events that involve the need of device removal.
To evaluate the preliminary efficacy of GlioHook, measured as Progression-Free Survival (PFS), defined according to RANO 2.0 criteria.
PFS will be defined as the time from the date of surgery to the date of first documented disease progression or death from any cause, whichever occurs first.
6 months Progression-Free Survival (PFS)
The 6-month PFS rate will also be reported. PFS will be defined as the time from the date of surgery to the date of first documented disease progression or death from any cause, whichever occurs first.
Adjuvant Progression-Free Survival (PFS)
PFS will be also analyzed from start of adjuvant treatment. PFS will be defined as the time from the start of adjuvant treatment to the date of first documented disease progression or death from any cause, whichever occurs first.
To evaluate the preliminary efficacy of GlioHook, measured as Overall Survival (OS).
Overall Survival (OS). OS will be defined as time from date of surgery to date of death from any cause. OS will be also analyzed from start of adjuvant treatment.
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Batea Oncology
Lead sponsor
Apices Soluciones S.L.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
