Nederlands: temozolomide Glioblastoma Multiforme dexamethason biodistributie Engels: temozolomide glioblastoma multiforme dexamethasone biodistribution
Conditions
Interventions
Patients will be PET-scanned twice (twice the combination of a [15O] H2O - and a [11C]temozolomide PET scan) on one day. One gift of 10 mg dexamethasone intravenously will be given between the morning
Sponsors
VU University Medical Center
Eligibility
Inclusion criteria
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; 3. Age between 18-70 years; 4. Performance status Karnofsky index > 60; 5. Laboratory requirements: A. Platelets > 100 x 109/l; B. Hb must be >8 mmol \ litre at the time of the screening for males and >7.5mmol \ litre for females; C. Neutrophils > 1.5 x 109/L; D. Liver- and kidney function: serum creatinine level < 1.5 times the upper limit of normal, liver function values <3 times the upper limit of normal. 6. All subjects have to be willing and able to give informed consent; 7. Written informed consent of each subject; 8. No use of DXM (at time of participation to this study).
Exclusion criteria
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; 3. Major psychiatric or neurological disorder other than GBM with or without epilepsy; 4. History of alcohol and/or drug abuse (DSM-IV criteria); 5. History of coagulation problems; 6. Claustrophobia; 7. Abnormalities on MRI other than GBM and/or abnormalities on MRI other than white matter changes or an incidental small lacunar lesion without clinical diagnosis; 8. Metal objects in or around the body (braces, pacemaker, metal fragments); 9. Use of antithrombotics or ASA; 10. Use of drugs that are known to be P-gp substrates, other than AEDs; 11. Need for elective surgery ≤ 6 weeks; 12. Pregnancy or nursing mothers; 13. Unable to understand or read the Dutch language; 14. Any of the following contra-indication for DXM (see also SPC of DXM): A. Hypersensitivity to one of the active constituents or additives; B. Ulcus ventriculi or ulcus duodeni; C. Active infections: viral infections, systemic fungal infections, parasitic infections, tropical worm infections; D. Recent vaccination with living weakened virus; E. Anamnestic hypersensibility for sulphite; F. History of glucocorticoid-induced myopathy; G. Diabetes mellitus (type 1 or 2).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. To assess plasma kinetics of [11C]temozolomide 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]temozolomide uptake in the brain and especially in the brain tumour. | — |
Contacts
Public ContactE.A.M. Froklage
P.O.Box 7057
Outcome results
None listed