The ultrasound glioma study.
Recruiting
- Conditions
- braintumor, gliomahersentumor, glioom
- Registration Number
- NL-OMON28737
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Individuals between 18-75 years
-Newly diagnosed, untreated, contrast enhancing presumed high-grade glioma
Exclusion Criteria
-Tumours crossing the midline basal ganglia, cerebellum,
or brain stem prohibiting gross total resection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The extent of resection will presented as a dichotomous outcome: gross-total resection or sub-total resection.<br>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.<br>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.<br>
- Secondary Outcome Measures
Name Time Method 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. <br>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. <br>