NCT05565118

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

Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma (WHO Grade III and IV) as a Predictor of Progression

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

High-grade gliomas are incurable primary brain tumors. Recent data support that glioma cells can integrate within neuronal circuits. Glioma cells and neurons communicate via electrical impulses and chemically, through neurotransmitters. This crosstalk has been shown to promote glioma cell migration and invasion in preclinical models. However, the nature of the electrical activity and underlying molecular mechanisms are poorly understood. The long-term goal of this study is to determine the impact of high electrical activity and pattern of activity on tumor invasion, and mechanistic basis of its regulation and functional consequences. This phase I safety and feasibility study is being proposed as a first step toward dissecting the connection between electrical activity and glioma behavior. The goal is to determine the safety and feasibility of recording electrical activity in the tumor-neuron interface using technologies that are already being used clinically for participants undergoing brain surgery.

Conditions

• High Grade Glioma
• Glioblastoma

Interventions

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

Timeline

• Start date: 2024-04-09
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-10-04
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States