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Intraoperative Brain Activity Monitoring for Brain Tumor
Phase 1
Recruiting
Led By Jennifer Yu, MD, PhD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study completion, an aim for 1 year post treatment
Awards & highlights
Study Summary
This trial will test if it is safe to take recordings of brain activity from patients with high-grade glioma tumors during surgery. A small sample will be taken from the recording sites.
Who is the study for?
This trial is for adults over 18 with high-grade gliomas visible on MRI, who've had a confirmed diagnosis and are undergoing surgery for recurrent tumors. They must be in good enough health to have surgery, not pregnant, without severe bleeding risks or major illnesses that could interfere with the study.Check my eligibility
What is being tested?
The study is testing the safety of recording brain activity from high-grade glioma tumors during surgery. Participants will receive standard surgical treatment along with intraoperative electrocorticography where brain activity is recorded and a small biopsy taken.See study design
What are the potential side effects?
Potential side effects may include typical surgical risks such as infection or bleeding at the biopsy site. Recording brain activity might also pose unknown risks due to its proximity to sensitive areas of the brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at study completion, an aim for 1 year post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion, an aim for 1 year post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility (Avoidance of unacceptable events)
No evidence of intracranial hemorrhage (grade 3 or higher)
No evidence of wound infection (grade 3 or higher)
Secondary outcome measures
Predict the area of progression in the peri-resection region of High Grade Gliomas based on electrical activity near the interface of the tumor and normal brain
Other outcome measures
Determine the correlation between peritumoral electrical activity (neuronal hyperexcitability) and degree of tumor infiltration.
Determine the effect of peritumoral electrical activity (neuronal hyperexcitability) on the peritumoral immune microenvironment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Standard Surgical Treatment + Intraoperative ElectrocorticographyExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,900 Total Patients Enrolled
15 Trials studying Glioblastoma
436 Patients Enrolled for Glioblastoma
Jennifer Yu, MD, PhDPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
1 Previous Clinical Trials
45 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding disorder that could make surgery risky.My brain tumor is in a critical area, needing special surgery.I am 18 years old or older.My recent lab tests show I'm fit for brain surgery.I can care for myself but may need occasional help.I had an MRI of my brain within the last month.My doctor thinks surgery is too risky for me due to other health issues.I have a glioma diagnosis and am having surgery again due to tumor growth.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Surgical Treatment + Intraoperative Electrocorticography
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has enrollment for this study opened up yet?
"The clinicaltrials.gov portal reveals that this medical trial, originally posted on January 1st 2023, is not recruiting any longer. However, 708 other trials with open enrollment are currently ongoing."
Answered by AI
Are there any risks associated with the combined use of Standard Surgical Treatment and Intraoperative Electrocorticography?
"As this is a Phase 1 trial, meaning there are only limited data affirming safety and efficacy of Standard Surgical Treatment + Intraoperative Electrocorticography, it received a score of 1 by our team at Power."
Answered by AI
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