GliomaCT-GlioHookNCT07725640
Feasibility Assessment of a Medical Device for Tumour Cell Retention and Radiotherapy Sensitization in Patients With Suspected High-grade Glioma
A study testing GlioHook device in people with Glioma and High-Grade Glioma (HGG), run by Batea Oncology at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma, High-Grade Glioma (HGG), Surgical Resection
- What is being tested?
- GlioHook device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesSpain
- Study dates
- 30 Oct 2026to 30 Oct 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and study procedures and accessible for follow-up after completion of study treatment.
- For women of childbearing potential (WOCBP):
- Must have a negative serum or urine pregnancy test within 7 days prior to inclusion.
- Must not be pregnant or breastfeeding at the time of inclusion.
- Must agree to use a highly effective method of contraception during the entire study participation period and for at least 6 months after the last dose of temozolomide.
- Male and female patients of reproductive potential must agree to use highly effective contraceptive methods.
Who cannot join
- 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:
Show all 21Show fewer
- Active infection requiring systemic therapy,
- Symptomatic congestive heart failure,
- Unstable angina pectoris,
- Clinically significant cardiac arrhythmia,
- Uncontrolled hypertension,
- Severe pulmonary, hepatic, or renal disease,
- Psychiatric or social conditions that, in the opinion of the investigator, would interfere with study compliance or follow-up.
- Severe blood clotting disorders
- 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.
- Contraindication to receive radiotherapy or temozolomide, including prior cranial irradiation exceeding safe cumulative dose limits.
- Participation in another interventional clinical trial or use of an investigational product within 30 days prior to inclusion, or planned participation during this clinical investigation.
- Women who are pregnant or breastfeeding.
- Men or women of reproductive potential unwilling to use adequate contraception, as defined in the inclusion criteria.
- Inability or unwillingness to comply with clinical investigation procedures, follow-up schedule, or CIP requirements, as judged by the investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites
Hospital Universitario Vall d'Hebron
Barcelona
Francisco Martínez Ricarte, MD
Francisco Martínez Ricarte, MD
Hospital HM Sanchinarro
Madrid
Juan Manuel Sepulveda Sánchez, MD
Juan Manuel Sepulveda Sánchez, MD
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela
Brais Rodríguez Botana, MD
Brais Rodríguez Botana, MD
About this study
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.
Read the detailed description
This clinical investigation is designed 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, in patients with high-grade glioma undergoing surgical resection followed by standard of care. Preliminary efficacy of the medical device such as Progression-Free Survival (PFS) will also be assessed.
- Conditions
- Glioma, High-Grade Glioma (HGG), Surgical Resection
- Being tested
- GlioHook device
- Keywords
- Implant, High-Grade Glioma, Radiotherapy, Temozolomide
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlioHook deviceDevice
Also called GlioHook
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | GlioHook implant in patients with high-grade glioma undergoing surgical resection followed by standard of care (SoC) treatment. Receives: Device: GlioHook device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (7)
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.
Measured: 24 months
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.
Measured: 6 months
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.
Measured: 24 months.
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.
Measured: 24 months
To evaluate changes in quality of life during the follow-up period (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30))
Percentage of patients maintaining stable or improved quality of life during the first 6 months of follow-up, compared with baseline.
Measured: 6 months
To evaluate changes in quality of life during the follow-up period (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Brain Cancer Module (EORTC QLQ-BN20))
Percentage of patients maintaining stable or improved quality of life during the first 6 months of follow-up, compared with baseline.
Measured: 6 months
To evaluate changes in neurological function during the follow-up period (Neurologic Assessment in Neuro-Oncology (NANO scale))
Percentage of patients maintaining stable or improved neurological function during the first 6 months of follow-up, compared with baseline.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Batea Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Apices Soluciones S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725640
- Sponsor's protocol ID
- CT-GlioHook-2026-01
- Acronym
- CT-GlioHook
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No