Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT03531333
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:
NCT03531333
Study Brief:
Protocol Section:
NCT03531333