NCT05565118 Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma as a Predictor of Progression
| NCT ID | NCT05565118 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | High Grade Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-04-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2024-04-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Jennifer Yu, MD, PhD
PRINCIPAL INVESTIGATOR
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT05565118 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying High Grade Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05565118 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05565118 currently recruiting?
Yes, NCT05565118 is actively recruiting participants. Contact the research team at taussigresearch@ccf.org for enrollment information.
Where is the NCT05565118 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05565118 clinical trial?
NCT05565118 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Jennifer Yu, MD, PhD at Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center. The trial plans to enroll 10 participants.