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

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Intraoperative Ultrasound Guidance and Extent of Resection in High Grade Glioma Surgery: a Randomised, Controlled Trial.

Conditions
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Glioma

Intervention / Treatment
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* Procedure: ultrasound guided surgery.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound<br>ultrasound navigation guided surgery. | Procedure: ultrasound guided surgery.<br>* during surgery, the neurosurgeon will acquire ultrasound guided images (fused with the standard neuronavigation system) to evaluate the progress of tumor resection.<br>|
| No Intervention: Non-ultrasound<br>standard surgery without ultrasound guidance. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross total resection (Yes or No) | Gross-total resection (yes vs. no): No residual contrast enhancement on post-operative MRI scans; 100% of all contrast enhancing tumor has been resected when compared to initial enhancing tumor on pre-operative MRI scans. | within 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of resection (%) | as a continous variable The extent of resection (%) is a secondary outcome measurement defined as the residual tumor volumes on post-operative MRI studies compared to the operative tumor volume. | within 48 hours after surgery | 
| Neurological outcome (Karnofsky Performance status) | Karnofsky Performance status | within 1 week after surgery | 
| Quality of Life (QLQ C30 questionnaires) | QLQ C30 questionnaires A brain tumor specific quality of life measurement tool | 1, 3 and 6 months after surgery | 
| Quality of Life (QLQ BN20 questionnaires) | QLQ BN20 questionnaires A brain tumor specific quality of life measurement tool | 1, 3 and 6 months after surgery | 
| Surgery associated neurological deficits (National Institutes of Health Stroke Scale) | National Institutes of Health Stroke Scale 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused typically by a stroke, however it is also used for tumor studies to assess functioning on the level of speech, motor and sensory functions. | 1 month after surgery | 
| Survival (time in days) | time measured from surgery until death in days. This study has a follow up of 6 months. However, when patients are alive at months after surgery, we will contact the general practictioner of the patient 15 months after the trial to obtain survival data. | status will be checked 15 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioma, intraoperative ultrasound, gross total resection, quality of life