To determine whether 18FGD-PET/CT imaging is able to show difference in [18F]-FDG uptake in orbital tissue between patients with active and inactive GO.
ID
Source
Brief title
Condition
- Thyroid gland disorders
- Ocular infections, irritations and inflammations
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Qualitative assessment of [18F]-FDG uptake in orbital tissue as imaged by the
PET/CT scan and comparison of data between subjects (or groups)
Secondary outcome
Semi-quantitative analysis of [18F]-FDG uptake as imaged by the PET/CT scan (a
standardized uptake value (SUV) is calculated)
Clinical Activity Score
Background summary
The assessment of disease activity in patients with Graves' orbitopathy (GO) is
important in deciding who and when to treat, with what treatment modality.
[18F]-fluorodeoxyglucose (FDG) positron emission tomography (PET) / computed
tomography (CT) is an imaging technique for the assessment of metabolic
activity. This technique is able to locate and identify inflammatory tissue.
Since GO is an inflammatory disease, the orbital tissue is expected to show an
increased FDG uptake. The value of FDG-PET/CT imaging in detecting, grading and
monitoring GO has not yet been determined. This study will investigate whether
18FGD-PET/CT imaging is able to show difference in [18F]-FDG uptake in orbital
tissue between patients with active and inactive GO.
Study objective
To determine whether 18FGD-PET/CT imaging is able to show difference in
[18F]-FDG uptake in orbital tissue between patients with active and inactive
GO.
Study design
Pilot study (observational case study)
Study burden and risks
The [18F]-FDG-PET/CT scan will be performed only once. Patients are not allowed
to eat 6 hours prior to the scan. During the 60 minute waiting period patients
will be asked to watch a video screen in order to minimize the difference in
eye movements between patients.
There is a risk of the development of a hematoma at the site where the venous
canule is inserted. No adverse effect events are to be expected during the
[18F]-FDG-PET/CT scanning. The total effective radiation dose is calculated at
4.3 mSv, this complies with category II-B of the international guidelines IRCP
62.
The ophthalmological evaluation is part of the routine medical treatment and an
extra inconvenience only for 3 out of 9 patients. For them it is not an unknown
procedure: all patients in group 3 have had this (or a similar) evaluation in
the past.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
> 18 years old and signed informed consent
Patients with Graves' orbitopathy (3 groups: higly active / moderately active / completely inactive)
Euthyroid >= 2 months
Exclusion criteria
Pregancy
Uncontrolled diabetes mellitus, or hyperglycemia prior to scan
For patients with active disease: currently receiving treatment for orbitopathy, or treatment ended < 3 months before entry
For patients with completely inactive disease: history of surgical decompression treatment
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 | NL37324.042.11 |