Intraoperative Ultrasound Guided Glioma Surgery; a Randomised, Controlled Trial.
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Glioma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure. The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .Masking: Single (Outcomes Assessor)Masking Description: Gross total resection (yes/no) on post-operative T1 postcontrast MRI scans will be evaluated by a neuroradiologist who is blinded for the treatment arm.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Study design: The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure. Study population: Fifty patients with newly diagnosed contrast enhancing presumed high grade glioma on first MRI scan. Intervention: The study consists of two treatment arms: non-ultrasound guide...
Study design: The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure. Study population: Fifty patients with newly diagnosed contrast enhancing presumed high grade glioma on first MRI scan. Intervention: The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) . Main study parameters/endpoints: Gross total resection (yes/no) Extent of resection (%) Neurological outcome (Karnofsky Performance Status) Quality of Life (EORTC QLQ-C30 and QLQ-BN20 quality of life questionnaire) Surgery associated neurological deficits (National Institutes of Health Stroke Scale) Adverse events (classified according to the US National Cancer Institute common toxicity criteria version 4.0) Survival time (days)
Tracking Information
- NCT #
- NCT03531333
- Collaborators
- Stichting Coolsingel
- Investigators
- Not Provided
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