18F-PSMA PET/CT for visualization of glioblastoma multiforme
Phase 2
Recruiting
- Conditions
- glioblastoma multiformehigh grade glioma10029211
- Registration Number
- NL-OMON48577
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
Inclusion Criteria
- Suspected GBM on MRI scan, - Scheduled for tumor resection at Radboudumc, -
Age *18 years
Exclusion Criteria
- Age < 18 years, - Pregnancy or the wish to become pregnant within 6
months, - Creatinine clearance below 40ml/min, - Liver disease defined as
aspartate aminotransferase or alanine aminotransferase level of more than three
times the upper limit of normal range
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* The uptake of 18F-PSMA PET/CT in suspected GBM lesions<br /><br>These data will be presented in a quantitative way. Activity is determined in a<br /><br>volume of interest (VOI) based on a relative threshold (>70% of the maximum<br /><br>voxel value within the VOI : VOI70%). Maximum standardized uptake in this VOI<br /><br>(SUVmax) and target to background ratios (TBR) are determined. </p><br>
- Secondary Outcome Measures
Name Time Method <p>* The correlation between PSMA protein and RNA expression with 18F-PSMA PET/CT<br /><br>uptake.<br /><br>PSMA protein and RNA expression will be presented in a quantitative way (FPKM<br /><br>as determined in targeted RNAsequencing analysis), and it will be plotted<br /><br>against 18F-PSMA uptake (SUVmax). Correlation will be described with the<br /><br>Pearsons correlation coefficient.<br /><br><br /><br>* Correlation between 18F-PSMA PET/CT and T1GdMRI<br /><br>Qualified radiologist and nuclear medicine physician will review the images and<br /><br>compare them qualitatively (tumor delineation etc).</p><br>