Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-07 @ 10:43 PM
Study NCT ID:
NCT03531333
Status:
UNKNOWN
Last Update Posted:
2020-01-13
First Post:
2017-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Ultrasound Guided Glioma Surgery; a Randomised, Controlled Trial.
Sponsor:
Erasmus Medical Center
Organization:
Study Overview
Official Title:
Intraoperative Ultrasound Guidance and Extent of Resection in High Grade Glioma Surgery: a Randomised, Controlled Trial.
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
US-GLIOMA
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: