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The ultrasound glioma study.


- candidate number24728
- NTR NumberNTR6033
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-aug-2016
- Secondary IDs49175//NL49175.078.15 ABR-nummer//METC Erasmus MC
- Public TitleThe ultrasound glioma study.
- Scientific TitleUltrasound Navigation Guided Improvement of High Grade Glioma Resection and Quality of Life: a phase III Randomized Controlled Trial. The US-GLIOMA Study
- ACRONYMUS-GLIOMA
- hypothesisUltrasound 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.
- Healt Condition(s) or Problem(s) studiedBrain tumor, Glioma
- Inclusion criteria- Individuals between 18-75 years
- Newly diagnosed, untreated, contrast enhancing presumed high-grade glioma
- KPS 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2016
- planned closingdate1-aug-2019
- Target number of participants0
- InterventionsThe study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .
- Primary outcomeThe 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 outcomeThe 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.
- Timepointspre operative
post operative
1 month post- operative
3 month post- operative
6 month post- operative
12 month post- operative
- Trial web sitewww.hersentumoronderzoek.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Fatih Incekara
- CONTACT for SCIENTIFIC QUERIES Fatih Incekara
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Stichting Coolsingel
- Publications
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD3-aug-2016 - 19-okt-2016


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