Intraoperative Ultrasound Guided Glioma Surgery; a Randomised, Controlled Trial. (US-GLIOMA)

Erasmus University

Status: Unknown

Conditions: Glioma

Treatments: Procedure: ultrasound guided surgery.

Study type: Interventional

Funder types: Other

Identifiers

NCT03531333

MEC-2015-46

Details and patient eligibility

About

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.

Full 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 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)

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Ultrasound

Experimental group

Description:

ultrasound navigation guided surgery.

Treatment:

Procedure: ultrasound guided surgery.

Non-ultrasound

No Intervention group

Description:

standard surgery without ultrasound guidance.