Feasibility Assessment of a Medical Device for Tumour Cell Retention and Radiotherapy Sensitizati… (NCT07725640) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility Assessment of a Medical Device for Tumour Cell Retention and Radiotherapy Sensitization in Patients With Suspected High-grade Glioma
Spain15 participantsStarted 2026-10-30
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Supratentorial and/or lobar tumor mass with a volume of less than 60cm3 as assessed by preoperative MRI.
. Patient scheduled to undergo surgical resection of the target brain lesion, with an expected extent of resection (EOR) ≥90% based on preoperative imaging and surgical planning and according to the investigator's criteria. The anticipated EOR should be verified intraoperatively using a validated available method depending on availability at study site, such as 5-aminolevulinic acid (5-ALA) fluorescence guidance, ultrasound, or MRI.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
. Candidate to receive standard-of-care treatment for newly diagnosed glioblastoma, according to current clinical practice and the investigator's judgment.
. Able to undergo contrast-enhanced MRI.
Exclusion criteria
. 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.
. Extent of tumor resection \<90%. The EOR should be verified intraoperatively using a validated available method depending on availability at study site, such as 5-aminolevulinic acid (5-ALA) fluorescence guidance, ultrasound, or MRI. However, it is up to the neurosurgeon to assess, after reviewing the available data and the resection itself, whether the patient meets the criteria for implantation.
. Significant active or uncontrolled concurrent medical conditions, including but not limited to:
. Known hypersensitivity to bovine-derived collagen or other components of the medical device.
. Contraindication to contrast-enhanced MRI, including known allergy to gadolinium or presence of non-MRI-compatible implants.