To establish criteria that differentiate between large-vessel vasculitis and atherosclerosis as a cause of enhanced vascular 18-FDG uptake on 18-FDG-PET/CT.
ID
Source
Brief title
Condition
- Other condition
- Vascular disorders NEC
Synonym
Health condition
atherosclerose (bloedvataandoeningen)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We anticipate that criteria relating to 18-FDG uptake distribution and
intensity, and presence of calcium deposits on low-dose CT, will differentiate
between vasculitis and atherosclerosis.
Secondary outcome
Not applicable
Background summary
The introduction of 18-FDG-PET/CT has caused a sharp increase in the frequency
of large-vessel vasculitis diagnoses. Arterial 18-FDG uptake may, however, also
be caused by atherosclerosis. Several factors that may differentiate between
these two entities have been suggested in literature. However, currently, no
qualitative, let alone quantitative criteria to differentiate vasculitis from
atherosclerosis have been formally studied and hence do not exist.
Study objective
To establish criteria that differentiate between large-vessel vasculitis and
atherosclerosis as a cause of enhanced vascular 18-FDG uptake on 18-FDG-PET/CT.
Study design
A single centre (VUmc) observational cohort study.
The study project consists of 3 phases:
1. Diagnostic accuracy of routine clinical assessments of PET-CT images typical
of atherosclerosis and vasculitis, respectively, without imposed assessment
criteria
2. Development of image assessment criteria for distinguishing atherosclerosis
and vasculitis
3. Observer variability and diagnostic accuracy of reading large-artery PET-CT
images using developed criteria
The total duration of the study is 1.5 years.
Study burden and risks
For the patients of group I there are no additional burdens or risks
The patients of group II should undergo a 18-FDG-PET/CT scan for which one
extra hospital visit is required and for which they must stop eating 6 hours
before the scan. Because of the PET/CT scan the patients will receive a minimal
radiation exposure and there is a risk of incidental findings,
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Group I:
Patients with biopsy-proven giant cell arteritis with any type/degree of large-artery 18-FDG-uptake in the absence of clues pointing to severe atherosclerosis (history of cardiovascular disease or a >2-fold increased age-adjusted CVD risk. Patient scans will be retrieved from our database.;Group II:
Patients with severe atherosclerosis affecting at least the thoracic and/or abdominal- iliacal aorta and any type/degree of large-artery 18-FDG uptake. Patients >50 years of age with manifest atherosclerotic disease will be selected from the vascular surgery outpatient clinic.
Exclusion criteria
Group I:
Use of immunosuppressive drugs
Known cancer
Reluctance or inability to provide informed consent;Exclusion criteria for group II:
ESR >30 mmHg and/or CRP >10 mg/l
Myalgia in shoulder/pelvic regions (suggestive of PMR)
History of vasculitis or other type of systemic auto-immune disease
Use of immunosuppressive drugs
Reluctance or inability to provide informed consent
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 | NL49373.029.14 |