No registrations found.
ID
Source
Brief title
Health condition
braintumor, glioma
hersentumor, glioom
Sponsors and support
Intervention
Outcome measures
Primary outcome
The extent of resection will presented as a dichotomous outcome: gross-total resection or sub-total resection.
Gross-total resection: No residual contrast enhancement on post-operative MRI scans (within 48 hours); 100% of all contrast enhancing tumor has been resected when compared to initial enhancing tumor on pre-operative MRI scans.
Sub-total resection: Residual contrast enhancement on post-operative MRI scans (within 48 hours); <100% of all contrast enhancing tumor has been resected when compared to initial enhancing tumor on pre-operative MRI scans.
Secondary outcome
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.
Patients will be followed for 6 months and the neurological outcome (KPS), Quality of Life (EORTC QLQ-C30,QLQ-BN20), surgery associated neurological deficits (measured 1 month after date of surgery), adverse events and time of survival (days) will be assessed as a secondary outcome measurement.
Background 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 purpose of this study is to investigate the effectivity of intraoperative navigated US in achieving GTR in patients with HGG, measure influence on quality of life and cost effectiveness.
Study objective
Ultrasound guided high grade glioma surgery succeeds gross total resection more frequently and improves quality of life and survival of time when compared with surgery without ultrasound guidance.
Study design
pre operative
post operative
1 month post- operative
3 month post- operative
6 month post- operative
12 month post- operative
Intervention
The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .
Inclusion criteria
- Individuals between 18-75 years
- Newly diagnosed, untreated, contrast enhancing presumed high-grade glioma
- KPS ¡Ý 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5853 |
| NTR-old | NTR6033 |
| Other | ABR-nummer//METC Erasmus MC : 49175//NL49175.078.15 |