Recording brain activity during surgery for high-grade glioma
Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma (WHO Grade III and IV) as a Predictor of Progression
This study is testing if recording brain activity during surgery for high-grade glioma tumors can help us understand how these tumors interact with brain cells to improve treatment options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05565118 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with high-grade glioma as confirmed by MRI or those undergoing resection of a recurrent/progressive tumor.
Not a fit: Patients with low-grade gliomas or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to improved treatment strategies for patients with high-grade gliomas.
How similar studies have performed: While the approach of recording electrical activity in gliomas is novel, similar studies have shown promise in understanding tumor behavior through neural interactions.
Eligibility criteria
Show full inclusion / exclusion 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) 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 this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.