Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma as a Predic… (NCT05565118) | Clinical Trial Compass
RecruitingPhase 1
Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma as a Predictor of Progression
United States10 participantsStarted 2024-04-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 determi…
What they're measuring
1
Correlation between electrical activity and anatomic region of progression based on follow-up contrast-enhanced MRI