This pilot study aims to confirm the feasibility of the PET scan procedure in 4 healthy volunteers to quantify NET binding in humans. This would then lay the foundation for intended future studies in our department investigating NET availability in…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
het betreft gezonde vrijwilligers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
30-min static data can be derived, after acquisition, from the 90-min dynamic
data. Several values will be computed and statistically compared against each
other: NET binding potentials (BP), standardized uptake values (SUV) and K
values will be computed for each region of interest (LC and projection areas),
which will then be used to compute ratios using appropriate reference tissue
models. Outcomes from both scan durations can be statistically compared. A
non-significant result will show that the 30-min data is as reliable as the
90-min data.
Secondary outcome
Not applicable.
Background summary
Noradrenaline (NA) is produced in the brain in the locus coeruleus (LC). NA and
its reuptake system, the noradrenaline transporter (NET), are implicated in a
wide range of cognitive functions, including attention, memory, and arousal. As
a result, the NA system is also of great interest in the context of
neurodegenerative disease such as Parkinson*s disease, Alzheimer*s disease, and
Alzheimer's dementia in Down syndrome, where such cognitive functions are
compromised. Recently, the identification of a suitable radiotracer for imaging
the NET using positron emission tomography (PET) has received growing
attention. The use of such a PET radiotracer enables the study of the NET
system in vivo. The most suitable of the currently available radiotracers is
[11C]methylreboxetine ([11C]MRB). [11C]MRB is being used worldwide in a growing
number of clinical studies. In this pilot study, the aim is to confirm previous
findings on scan time reduction. This entails deriving 30-min static data from
the acquired 90-min dynamic data.
Study objective
This pilot study aims to confirm the feasibility of the PET scan procedure in 4
healthy volunteers to quantify NET binding in humans. This would then lay the
foundation for intended future studies in our department investigating NET
availability in patients with neurodegenerative diseases to characterize NA
system degeneration underlying these diseases.
Study design
The proposed pilot study will use PET imaging with the [11C]MRB radiotracer
allowing in vivo examination of NET availability in the locus coeruleus and key
projection areas (cortex, hippocampus).
Study burden and risks
This study entails a minimum risk to the participants. In general, PET imaging
is a procedure with minimal adverse effects. Intravenous injection of the
tracer is minimally invasive. The concentration of the [11C]MRB tracer used in
this study does not have a pharmacological effect nor is it expected to cause
adverse effects. Participants do not directly benefit from the study. Outcomes
of this study will contribute to optimization of the study procedure before
applying it to groups of patients with neurodegenerative diseases.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
age between 50 and 80 years
Exclusion criteria
- past or present developmental disorder or psychiatric disorder
- abnormal results on the MMSE (<27)
- (subjective) memory complaints
- presence of any contra-indication for PET scanning
- participation in PET study in the last 12 months
- use of any medication that acts on the noradrenaline system
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003259-12-NL |
| CCMO | NL68875.042.19 |
| Other | TBA (trialregister.nl) |