Feasibility Assessment of a Medical Device for Tumour Cell Retention and Radiotherapy Sensitization in Patients With Suspected High-grade Glioma

NCT07725640 | Not Yet Recruiting DMC

• 1 other identifier: CT-GlioHook-2026-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Glioma; High-Grade Glioma (HGG); Surgical Resection

Keywords

Implant; High-Grade Glioma; Radiotherapy; Temozolomide

Outcome Measures

Primary Outcomes (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

  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.

  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.

  24 months

• 6 months Progression-Free Survival (PFS)

  6 months

• Adjuvant Progression-Free Survival (PFS)

  24 months.

• To evaluate the preliminary efficacy of GlioHook, measured as Overall Survival (OS).

  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))

  6 months

Study Arms (1)

Experimental Arm

EXPERIMENTAL

GlioHook implant in patients with high-grade glioma undergoing surgical resection followed by standard of care (SoC) treatment.

Device: GlioHook device

Interventions

GlioHook device DEVICE

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.

Also known as: GlioHook

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Batea Oncology: lead
• Apices Soluciones S.L.: collaborator

Study Sites (3)

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Location

Hospital HM Sanchinarro

Madrid, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

BATEA Oncology

CONTACT

0; contact@bateaoncology.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

ES (3)