Intraoperative Ultrasound Guided Glioma Surgery; a Randomised, Controlled Trial.

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)

Inclusion Criteria:

• Individuals of 18 years or older
• Newly diagnosed, untreated, contrast enhancing presumed high-grade glioma
• KPS ≥ 60
• Preoperative intention to perform gross-total resection of the enhancing tumor
• Written informed consent conform ICH-GCP

Exclusion Criteria:

• Tumours crossing the midline basal ganglia, cerebellum, or brain stem prohibiting gross total resection
• Multifocal contrast enhancing lesions
• Pre-existing neurological deficit (e.g. aphasia, hemiparesis) due to neurological diseases (e.g. stroke)
• Inability to give consent because of dysphasia or language barrier