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Recruiting Phase 1 NCT05565118

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

Trial Parameters

Condition High Grade Glioma
Sponsor Case Comprehensive Cancer Center
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 10
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-04-09
Completion 2026-12
Interventions
Standard Surgical TreatmentIntraoperative Electrocorticography

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.

Eligibility Criteria

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

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