The effect of dexamethasone on the biodistribution of [3-N-11C-methyl]temozolomide in glioblastoma multiforme patients

• Conditions: 10029211; glioblastoma multiforme and malignant brain tumor

• Registration Number: NL-OMON37565
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 12

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 < 1.5 times the upper limit of normal, liver function values <3 times the upper limit of normal
- No use of DXM (at time of participation to this study)

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 <= 6 weeks
- Pregnancy or nursing mothers
- Unable to understand or read the Dutch language
- Any of the following contra-indication for DXM (see also SPC of DXM):
- Hypersensitivity to one of the active constituents or additives
- Ulcus ventriculi or ulcus duodeni
- Active infections: viral infections, systemic fungal infections, parasitic infections, tropical worm infections
- Recent vaccination with living weakened virus
- Anamnestic hypersensibility for sulphite
- History of glucocorticoid-induced myopathy
- Diabetes mellitus (type 1 or 2)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The influence of dexamethasone on the biodistribution of [11C]TMZ in the brain. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) To assess plasma kinetics of [11C]TMZ in humans, including assessment of the<br /><br>presence of radioactive metabolites.<br /><br><br /><br>2) To study the effect of DXM on CBF.<br /><br><br /><br>3) If there is an effect of DXM on CBF, we will study the relation between<br /><br>changes in CBF and [11C]TMZ uptake in the brain and especially in the brain<br /><br>tumor.</p><br>