braintumor, glioma hersentumor, glioom
Conditions
Interventions
The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .
Sponsors
Erasmus Medical Center
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactFatih Incekara
Outcome results
None listed