Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma as a Predictor of Progression
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Standard Surgical Treatment
Procedure/SurgeryDuring this surgery, participants will also undergo a tissue biopsy at recording sites for correlation to neural recording data.
Intraoperative Electrocorticography
Procedure/SurgeryEach participant will undergo intraoperative electrocorticography (ECOG) through subdural grid (SDG) and depth electrode (DE) via FDA-cleared, standardized, brain recording technology.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Standard Surgical Treatment + Intraoperative ElectrocorticographyExperimental treatment 2 interventions
Trial outcomes
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
Time frame
Up to 9 months post surgeryOther 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
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.
Time frame
At study completion, an aim for 1 year post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Case Comprehensive Cancer Center
Lead sponsor
Burkhardt Brain Tumor and Neuro-Oncology Center
Collaborator
Source ClinicalTrials.gov