RECRUITING

Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma as a Predictor of Progression

Conditions

High Grade Glioma Glioblastoma Neural Recording Electrical Activity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma (WHO Grade III and IV) as a Predictor of Progression

Quick Facts

Study Start:2024-04-09

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05565118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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).	* 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

Inclusion Criteria

Exclusion 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
* 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).

* 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

Contacts and Locations

Study Contact

Jennifer Yu, MD, PhD

CONTACT

1-866-223-8100

taussigresearch@ccf.org

Principal Investigator

Jennifer Yu, MD, PhD

PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Locations (Sites)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

Jennifer Yu, MD, PhD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-09

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2024-04-09

Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

High Grade Glioma
Glioblastoma
Neural Recording
Electrical Activity

Additional Relevant MeSH Terms

High Grade Glioma
Glioblastoma