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New treatment option for High Grade Glioma
Official title Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma as a Predictor of Progression
ClinicalTrials.gov ID: NCT05565118
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Participants with a history of histologically-confirmed diagnosis of high- grade glioma that are undergoing resection of a recurrent/progressive...
- Age ≥ 18 years old
- Volumetric MRI within 1 month prior to surgery
- Karnofsky performance status of 60 or higher
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.