The effect of dexamethasone on the biodistribution of [3-N-11C]temozolomide in glioblastoma multiforme patients.
Recruiting
- Conditions
- ederlands:temozolomideGlioblastoma MultiformedexamethasonbiodistributieEngels: temozolomideglioblastoma multiformedexamethasonebiodistribution
- Registration Number
- NL-OMON29066
- Lead Sponsor
- VU University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
1. Histopathological confirmed diagnosis of GBM;
2. Remainder of tumor on post-(chemo)irradiation follow-up MRI; this remainder of tumor must be at least 5 mm in diameter;
Exclusion Criteria
1. Any clinical significant abnormality of any clinical laboratory test, with the exception of the values mentioned above (for platelets, haemoglobin, neutrophils, kidney- and liver function);
2. Any subject who has received any investigational medication within 30 days prior to the start of this study, or who is scheduled to receive an investigational drug;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of the effect of dexamethasone on the biodistribution of [3-N-11C-methyl]temozolomide in GBM patients during the adjuvant phase of chemotherapy.
- Secondary Outcome Measures
Name Time Method 1. To assess plasma kinetics of [11C]temozolomide in humans, including assessment of the presence of radioactive metabolites;<br /><br>2. To study the effect of DXM on CBF;<br /><br>3. If there is an effect of DXM on CBF, we will study the relation between changes in CBF and [11C]temozolomide uptake in the brain and especially in the brain tumour.