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
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Jennifer Yu, MD, PhD
taussigresearch@ccf.org
1-866-223-8100
Time Frame
Start Date: 2024-04-09
Estimated Completion Date: 2026-12
Participants
Target number of participants: 10
Treatments
Experimental: Standard Surgical Treatment + Intraoperative Electrocorticography
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.
Sponsors
Leads: Case Comprehensive Cancer Center
Collaborators: Burkhardt Brain Tumor and Neuro-Oncology Center

This content was sourced from clinicaltrials.gov

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