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.
ID
Bron
Verkorte titel
Aandoening
braintumor, glioma
hersentumor, glioom
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
pre operative
post operative
1 month post- operative
3 month post- operative
6 month post- operative
12 month post- operative
Onderzoeksproduct en/of interventie
The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5853 |
| NTR-old | NTR6033 |
| Ander register | ABR-nummer//METC Erasmus MC : 49175//NL49175.078.15 |