Primary: to determine normal values and test-retest variation of salivary gland perfusion using ASL in healthy volunteers. Secondary: to test the procedure by measuring possible perfusion differences during stimulated or suppressed salivation.
ID
Source
Brief title
Condition
- Endocrine and glandular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The semi-quantitative perfusion signal will be measured on ASL MR maps from
representative slices of the parotid and submandibular glands. Perfusion will
be expressed in mL/min/100g tissue. This will be used to calculate the normal
value (median) with confidence interval per gland type. The variation between
separate scans will be used to calculate the intra- and inter-day variation.
Secondary outcome
The detectability of effects will be estimated based on comparison of baseline
scans with intervention scans (stimulation or suppression of salivation).
Background summary
Salivary toxicity may be induced by several treatment modalities, and can lead
to a dry mouth with severe impact on quality of life. Reducing the perfusion of
salivary glands can potentially lower toxicity from many pharmaceuticals. To
test such interventions a non-invasive and non-toxic instrument is needed to
evaluate local perfusion. ASL MR is a commercially available method to measure
perfusion of tissues, without intravenous contrast and with CE-mark. The
application for evaluation of perfusion in salivary glands is new, and
therefore normal values and test-retest values are currently unknown.
Study objective
Primary: to determine normal values and test-retest variation of salivary gland
perfusion using ASL in healthy volunteers. Secondary: to test the procedure by
measuring possible perfusion differences during stimulated or suppressed
salivation.
Study design
On day 1, volunteers will receive two baseline MRI scans with ASL sequence
within a few hours (intra-day test-retest variation). On day 2, volunteers will
receive one baseline MRI scan with ASL sequence (multi-day test-retest
variation), and one with either stimulation or suppression (effect evaluation).
Intervention
The first 3 scans have no intervention. De last scan will be acquired during
stimulation or suppression of salivation (random). Stimulation of salivation is
achieved by citric acid, smelling food or thinking of food. Suppression of
salivation is achieved by cooling of salivary glands with household cooling
packs.
Study burden and risks
Four ASL MRI scans will be acquired, divided over 2 days. One scan takes max 30
minutes. There are no significant risks for well-screened healthy volunteers.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteer.
Exclusion criteria
Age <18.
Inability to provide informed consent.
History of disease of the salivary glands.
Contra-indications for MR.
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 | NL65464.031.18 |