Therefore, the aim of this study will be to assess reproducibility of pseudo-CASL (p-CASL) between 3.0 Tesla MR scanners of two vendors in two medical centers.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Geen aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
CBF (mL per 100 grams of brain tissue per minute) as assessed by ASL at 3.0 T
MRI
Secondary outcome
NA
Background summary
Arterial spin labeling (ASL) is a non-invasive magnetic resonance imaging (MRI)
technique for the quantification of perfusion. From all MRI perfusion
modalities, it is the only one that is harmless, not hampered by blood-brain
barrier breakdown and acquires absolute quantification of perfusion.
Reproducibility of ASL CBF measurements remains an important concern when using
ASL in clinical routine. Until now, reproducibility studies have focused on
single center and single vendor designs and did not compare results obtained
from scanners of different vendors. (2-5,16,18). When using ASL in clinical
practice, knowledge of the variability in and between scanning sessions and
variability between MR scanners is of utmost importance to correctly interpret
perfusion changes over time. Moreover, it is important to take inter-vendor (or
inter-center) reproducibility into account in the definition of reference
values for CBF.
Study objective
Therefore, the aim of this study will be to assess reproducibility of
pseudo-CASL (p-CASL) between 3.0 Tesla MR scanners of two vendors in two
medical centers.
Study design
To assess the reproducibility, the inter-vendor reproducibility will be
compared to the intra-vendor reproducibility. To assess the intra-vendor
reproducibility of p-CASL, we will perform p-CASL measurements in two distinct
MRI-examinations in each center. To study the inter-vendor (or inter-center)
reproducibility of p-CASL, we will compare CBF at the two locations.
Intervention
200 mg. cafeine per scan
Study burden and risks
This study is conducted using a non-invasive imaging modality: MRI. MRI is
considered harmless. Participants will be extensively screened for
contraindications by an experienced researcher upon inclusion in the study. All
scans are reviewed for incidental findings by a Neuroradiologist (dr. M.
Smits). If clinically relevant abnormalities on the MR images are apparent, the
volunteer is informed and a specialist will be consulted. The consumption of
200 mg of caffeine is comparable to the amount of caffeine ingested when
drinking 2 cups of coffee. Health risks associated with consuming 200 mg of
caffeine are highly unlikely in healthy volunteers, but possible side effects
of 200-250 mg may include insomnia, agitation, nervousness, mild delirium and
bradycardia.
's Gravendijkwal 230
3015 CE
NL
's Gravendijkwal 230
3015 CE
NL
Listed location countries
Age
Inclusion criteria
• healthy adult volunteers, between 18 to 40 years of age
• non-smoking
• informed consent
Exclusion criteria
• inability of the patient to provide informed consent or legally incompetent/incapacitated to do so
• presence of metal in the body (e.g. osteosynthetic material, pacemaker, artificial cardiac valves)
• claustrophobia
• history of brain surgery
• history of brain or psychiatric disease
• use of medication with the exception of oral contraceptives.
Design
Recruitment
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 |
|---|---|
| CCMO | NL39853.078.12 |