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| Name | Class |
|---|---|
| Burkhardt Brain Tumor and Neuro-Oncology Center | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Surgical Treatment | Procedure | During this surgery, participants will also undergo a tissue biopsy at recording sites for correlation to neural recording data. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Yu, MD, PhD | Contact | 1-866-223-8100 | taussigresearch@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Yu, MD, PhD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Recruiting | Cleveland | Ohio | 44195 | United States |
Aggregate data will be shared, while individual data will not need to be shared.
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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.
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| 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. |
|
| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |
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