glioblastoma multiforme and malignant brain tumor
Conditions
Interventions
One gift of 10mg dexamethasone between morning- and afternoon scanning session.
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Histopathological confirmed diagnosis of GBM - Remainder of tumor on post-irradiation follow-up MRI - Age between 18-70 years - Performance status Karnofsky index > 60 - Laboratory requirements: - Platelets > 100 x 109/l - Hb must be >8 mmol \ litre at the time of the screening for males and >7.5mmol \ litre for females - Neutrophils > 1.5 x 109/L - Liver- and kidney function: serum creatinine level
Exclusion criteria
Exclusion criteria: - 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) - 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 - Major psychiatric or neurological disorder other than GBM with or without epilepsy - History of alcohol and/or drug abuse (DSM-IV criteria) - History of coagulation problems - Claustrophobia - Abnormalities on MRI other than GBM (and related abnormalities such as edema) and/or abnormalities on MRI other than white matter changes or an incidental small lacunar lesion without clinical diagnosis - Metal objects in or around the body (braces, pacemaker, metal fragments) - Use of antithrombotics or ASA - Use of drugs that are known to be P-gp substrates, other than AEDs - Need for elective surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The influence of dexamethasone on the biodistribution of [11C]TMZ in the brain. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To assess plasma kinetics of [11C]TMZ in humans, including assessment of the presence of radioactive metabolites. 2) To study the effect of DXM on CBF. 3) If there is an effect of DXM on CBF, we will study the relation between changes in CBF and [11C]TMZ uptake in the brain and especially in the brain tumor. | — |
Countries
Netherlands
Outcome results
None listed