Glioma Clinical Trial
Official title:
Intraoperative Ultrasound Guidance and Extent of Resection in High Grade Glioma Surgery: a Randomised, Controlled Trial.
The main goal of high grade glioma (HGG) surgery is to achieve gross total resection (GTR) without causing new neurological deficits1-8. Intraoperative navigated high resolution ultrasound (US) is a promising new tool to acquire real-time intraoperative images to localize and to resect gliomas9-12. The aim of this study was to investigate whether intraoperative guided surgery leads to a higher rate of GTR, when compared with standard non-ultrasound guided surgery.
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)
;
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