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

Not Applicable

• Conditions: Glioma
• Interventions: Procedure: ultrasound guided surgery.

• Registration Number: NCT03531333
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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

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)

Study Timeline

• Study Start: 2016-11-01
• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-21
• Primary Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	ultrasound guided surgery.	ultrasound navigation guided surgery.

Primary Outcome Measures

Name	Time	Method
Gross total resection (Yes or No)	within 48 hours after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Neurological outcome (Karnofsky Performance status)	within 1 week after surgery	Karnofsky Performance status
Quality of Life (QLQ BN20 questionnaires)	1, 3 and 6 months after surgery	QLQ BN20 questionnaires; A brain tumor specific quality of life measurement tool
Quality of Life (QLQ C30 questionnaires)	1, 3 and 6 months after surgery	QLQ C30 questionnaires; A brain tumor specific quality of life measurement tool
Surgery associated neurological deficits (National Institutes of Health Stroke Scale)	1 month after surgery	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.
Extent of resection (%)	within 48 hours after surgery	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.
Survival (time in days)	status will be checked 15 months after surgery	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.

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands