Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2001-02-28
2007-01-31
Brief Summary
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Detailed Description
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PK11195 (1-(2-chlorophenyl)-N-methyl-N-1(1-methylpropyl)-3 isoquinolinecarboxamide) is a highly specific ligand for the peripheral benzodiazepine-binding site, which is particularly abundant on cells of the mononuclear macrophage line (Myers et al., 1991). In normal human brain, the peripheral-type benzodiazepine receptor ligand PK11195 exhibits low to minimal binding primarily associated with the choroid plexus, ependymal linings and glial cells. However, following neuronal damage, the cells involved in the ensuing gliosis, microglia, show a marked increase in expression of these sites (Stephenson et al., 1995;Conway et al., 1998).
PK11195 labeled with carbon-11 is a PET ligand to peripheral type benzodiazepine receptors which has already been used in patients with stroke (Ramsay et al., 1992), Rasmussen's encephalitis (Banati et al., 1999), multiple sclerosis (Banati et al., 1997) and facial nerve lesions (Myers et al., 1999). However, no tracer kinetic model for quantification has been fully validated for(R)-\[11C\]PK11195. In order to use (R)-\[11C\]PK11195 for PET-imaging of microglia activation and to use it in the longitudinal monitoring of disease progression, baseline levels of ligand uptake in a healthy control population are required. This study aims to measure (R)-\[11C\]PK11195 uptake in normal brain in different age groups and to develop methods for quantification of specific binding of (R)-\[11C\]PK11195. Because (R)-\[11C\]PK11195 uptake depends on regional bloodflow, each (R)-\[11C\]PK11195 scan will be preceded by a cerebral bloodflow scan with H215O.
OBJECTIVES
* Determine the distribution of (R)-\[11C\]PK11195 in normal brain
* Develop methods for quantification of specific binding of (R)-\[11C\]PK11195
* Determine the metabolic profile of (R)-\[11C\]PK11195 in healthy volunteers
DESIGN OF THE STUDY Forty healthy subjects will be recruited, 20 males and 20 females. This is an open study. The study consists of one PET scan, which will be performed at the Department of Nuclear Medicine \& PET research of the VU University Medical Centre.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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Positron Emission Tomography
Eligibility Criteria
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Inclusion Criteria
* Good physical and mental Health which will be evaluated with medical history, a physical examination and screening laboratory tests (see appendix 1).
* Age between 18 and 40 years (20 subjects) and between 40 and 80 years (20 subjects).
* Mini Mental State score \>27
* Body Mass Index (B.M.I.) between 20 -25.
* Written informed consent of the subject.
* Hb must be \>8 mmol \\ liter at the time of the screening.
Exclusion Criteria
* Any clinical significant abnormality of any clinical laboratory test, including drug screening, or ECG abnormality.
* History of hypertension
* 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.
* History of psychiatric or neurological illness
* History of psychiatric or neurological illness in first-degree relatives
* History of alcohol and/or drug abuse (DSM-IV criteria)
* Current use of any medication
* Blood donation within 3 months before the scan day
* Claustrophobia
* Metal objects in or around the body (braces, pacemaker, metal fragments);
18 Years
80 Years
ALL
Yes
Sponsors
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Amsterdam UMC, location VUmc
OTHER
Principal Investigators
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Bart van Berckel, MD; PhD
Role: PRINCIPAL_INVESTIGATOR
VUmc Medical Centre
Locations
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VU University Medical Centre
Amsterdam, , Netherlands
Countries
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Other Identifiers
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no other ID's
Identifier Type: -
Identifier Source: secondary_id
2001/001
Identifier Type: -
Identifier Source: org_study_id