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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05565118
• Other study ID #: CASE4321
• Status: Recruiting
• Phase: Phase 1
• Start date: April 9, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: Case Comprehensive Cancer Center
• Contact: Jennifer Yu, MD, PhD
• Phone: 1-866-223-8100
• Email: taussigresearch[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 OR
• 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).

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Glioblastoma
• Glioma
• High Grade Glioma

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	Burkhardt Brain Tumor and Neuro-Oncology Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between electrical activity (neuronal hyperexcitability) in brain surrounding the enhancing tumor and cellular and molecular profile of the tumor and its microenvironment	Electrical activity will be assessed as described above and correlated with transcriptomic changes. Bioinformatics analyses including gene ontology analyses and multi-dimensional network analyses will be performed.	At study completion, an aim for 1 year post treatment
Primary	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