Recording brain activity during surgery for high-grade glioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and feasibility of recording electrical activity in and around high-grade glioma tumors during surgical procedures. By taking small biopsies at the recording sites, researchers hope to understand how glioma cells interact with neurons through electrical impulses and neurotransmitters. The long-term goal is to explore the relationship between electrical activity patterns and tumor behavior, which could lead to better treatment strategies. This phase I study represents an initial step in investigating the connection between electrical activity and glioma progression.

Why it matters

Who can join: the full rules

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) 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).

Exclusion Criteria:

* 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
* Tumor location requiring DE placement/biopsy in eloquent or critical region of the brain (e.g. primary motor and sensory cortices, speech and vision centers, thalamus, basal ganglia, cerebellum, brain stem) as deemed by the neurosurgeon designing the surgical plan

Where it's running

• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Jennifer Yu, MD, PhD — Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
• Study coordinator: Jennifer Yu, MD, PhD
• Email: taussigresearch@ccf.org
• Phone: 1-866-223-8100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing two surgical approaches for high-grade glioma patients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.