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

Glioma Clinical Trial

— US-GLIOMA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03531333
• Other study ID #: MEC-2015-46
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: August 1, 2020

Study information

• Verified date: January 2020
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma

Intervention

Procedure:
• ultrasound guided surgery.
during surgery, the neurosurgeon will acquire ultrasound guided images (fused with the standard neuronavigation system) to evaluate the progress of tumor resection.

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Stichting Coolsingel

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Neurological outcome (Karnofsky Performance status)	Karnofsky Performance status	within 1 week after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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