Recruiting
Phase 1

Observational Study

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT05565118

Conditions

High Grade Glioma

Glioblastoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard Surgical Treatment

Intraoperative Electrocorticography

Study Details

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.

Conditions

High Grade Glioma

Glioblastoma

Study ID

NCT05565118

Start date

Apr 9, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Standard Surgical Treatment

During this surgery, participants will also undergo a tissue biopsy at recording sites for correlation to neural recording data.

Intraoperative Electrocorticography

Each participant will undergo intraoperative electrocorticography (ECOG) through subdural grid (SDG) and depth electrode (DE) via FDA-cleared, standardized, brain recording technology.

Primary outcome measure

  • Correlation between electrical activity and anatomic region of progression based on follow-up contrast-enhanced MRI [ Time Frame: Up to 9 months post surgery ]

Central Contacts and Locations

Central contacts

Jennifer Yu, MD, PhD

1-866-223-8100taussigresearch@ccf.org

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Jennifer Yu, MD, PhD

866-223-8100taussigresearch@ccf.org

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • High Grade Glioma
  • Glioblastoma
  • Neural Recording
  • Electrical Activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-06.