Trials / Unknown
UnknownNCT03531333
Intraoperative Ultrasound Guided Glioma Surgery; a Randomised, Controlled Trial.
Intraoperative Ultrasound Guidance and Extent of Resection in High Grade Glioma Surgery: a Randomised, Controlled Trial.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Erasmus Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2019-12-31
- Completion
- 2020-08-01
- First posted
- 2018-05-21
- Last updated
- 2020-01-13
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03531333. Inclusion in this directory is not an endorsement.