Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma as a Predictor of Progression

NCT05565118 | Recruiting Phase 1

• 1 other identifier: CASE4321
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety and feasibility of recording brain activity within and around high-grade glioma tumors at the time of surgery. A small biopsy will be taken at the sites of the recordings.

Conditions

High Grade Glioma; Glioblastoma

Keywords

High Grade Glioma; Glioblastoma; Neural Recording; Electrical Activity

Outcome Measures

Primary Outcomes (1)

• Correlation between electrical activity and anatomic region of progression based on follow-up contrast-enhanced MRI

  To describe the pattern of electrical activity (neuronal hyperexcitability) in brain surrounding the enhancing tumor during open surgery in patients with high grade gliomas and its correlation with progression

  Up to 9 months post surgery

Other Outcomes (1)

• Correlation between electrical activity (neuronal hyperexcitability) in brain surrounding the enhancing tumor and cellular and molecular profile of the tumor and its microenvironment

  At study completion, an aim for 1 year post treatment

Study Arms (1)

Standard Surgical Treatment + Intraoperative Electrocorticography

EXPERIMENTAL

Each participant will undergo intraoperative electrocorticography (ECOG) through subdural grid (SDG) and depth electrode (DE) via FDA-cleared, standardized, brain recording technology. During this surgery, participants will also undergo a tissue biopsy at recording sites for correlation to neural recording data.

Procedure: Standard Surgical Treatment; Procedure: Intraoperative Electrocorticography

Interventions

Standard Surgical Treatment PROCEDURE

During this surgery, participants will also undergo a tissue biopsy at recording sites for correlation to neural recording data.

Standard Surgical Treatment + Intraoperative Electrocorticography

Intraoperative Electrocorticography PROCEDURE

Each participant will undergo intraoperative electrocorticography (ECOG) through subdural grid (SDG) and depth electrode (DE) via FDA-cleared, standardized, brain recording technology.

Standard Surgical Treatment + Intraoperative Electrocorticography

Eligibility Criteria

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

You may qualify if:

• Participants who have the appearance of high-grade glioma (HGG, WHO Grade 3 and 4, including GBM) on MR imaging are allowed to consent and will undergo the procedure if the frozen is consistent with HGG
• Participants with a history of histologically-confirmed diagnosis of high- grade glioma that are undergoing resection of a recurrent/progressive tumor that is likely recurrent/progressive high- grade glioma as identified on preoperative MR imaging
• Age ≥ 18 years old
• Volumetric MRI within 1 month prior to surgery
• Karnofsky performance status of 60 or higher
• The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
• Participants must be considered appropriate neurosurgical candidates with the following screening/baseline laboratory values within 1 month prior to surgery:
• Absolute neutrophil count ≥ 1500/µL
• Platelets ≥ 100 000/µL
• International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × Upper limit of normal (ULN) unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
• Urine or Serum Pregnancy Test = Negative (Not applicable to participants with bilateral oophorectomy and/or hysterectomy or to those participants who are postmenopausal).

You may not qualify if:

• Severe co-morbidity that would confer excess risk of surgery as determined by the treating physician.
• Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
• Is pregnant
• Coagulopathy or platelet dysfunction that increases the risk of intra and postoperative hemorrhage
• Tumor location requiring DE placement/biopsy in eloquent or critical region of the brain (e.g. primary motor and sensory cortices, speech and vision centers, thalamus, basal ganglia, cerebellum, brain stem) as deemed by the neurosurgeon designing the surgical plan

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• Burkhardt Brain Tumor and Neuro-Oncology Center: collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Jennifer Yu, MD, PhD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Yu, MD, PhD

CONTACT

1-866-223-8100; taussigresearch@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants undergoing surgical resection will have a regional recording of neuronal electrical activity that will be measured in a minimum of 4 peritumoral anatomic zones via depth electrodes, overlying the cortex of the lesion via a subdural grid, within the presumed tumor, and in adjacent presumed normal brain. Recording findings specific to these anatomo-electro-clinical zones will be correlated with the presence/degree of contrast-enhancing tumor on MRI at recurrence. Additionally, biopsies will be obtained in these depth electrode regions for correlative studies.

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 4, 2022
• Study Start: April 9, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)