Giant Cell Arteritis, Large Vessel Giant Cell Arteriitis
Conditions
Keywords
magnet resonance imaging (MRI), Positron emission tomography/computer tomography (PET/CT), GCA relapse
Brief summary
Longitudinal imaging in patients with large vessel vasculitis to predict further disease course
Detailed description
This explorative longitudinal prospective observational study is to explore different aspects of vessel wall characteristics as detected by magnet resonance imaging (MRI) techniques and positron emission tomography/computer tomography (PET/CT) in patients with large vessel giant cell Arteriitis (LV-GCA) for their usefulness as predictive factor for future giant cell arteritis (GCA) relapse. It analyses parameters in PET/CT and MRI in patients with GCA at treatment stop which correlate with GCA relapse within the first 6 months after treatment stop. Patients included in the established local GCA database (BARK) will be screened for eligibility. Aortal imaging is performed during routine care according to established guidelines at diagnosis and during Follow Up at least every two years and before treatment stop.
Interventions
DIAGNOSTIC_TESTMagnet Resonance Imaging (MRI)
MRI with and without Gadolinium contrast agent for the following vessels: thoracic aorta (ascending, arch, descending arch, left and right common carotic, subclavian, and vertebral artery)
DIAGNOSTIC_TESTPET/CT analysis
Standard value uptake measurement (SUV) based on quantitative score normalized to liver (SUV vessel max/liver mean) at the following vessel regions: Carotid artery: common, internal, external; Subclavian artery; Axillary artery; Vertebral artery; Thoracic Aorta; Abdominal Aorta; Common femoral artery; Deep femoral artery; Popliteal artery
Sponsors
Swiss Foundation for the Study of Muscular Diseases
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of GCA and having a diagnosis of LV-GCA confirmed by imaging (PET/CT) * Informed consent to the local GCA cohort BARK * Followed for GCA treatment in the outpatient department.
Exclusion criteria
* Known hypersensitivity or allergy to Gadolinium (Gd)-based MRI contrast agents. * Patients with cardiac pacemakers, intra cranial clips, metallic foreign bodies or other not MR-compatible implants (e.g. pumps etc.). * Renal failure or severely impaired kidney function (eGFR \< 30 ml/min /1,73 m2) * Epilepsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mural thickening at MRI analysis | at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start) | 0 = no mural thickening (maximal vessel wall thickness \<2 mm for aorta, \<1mm for its branches) 1. = mural thickening (2-3 mm for aorta, 1-2 mm for its branches); 2. = strong thickening (\>3 mm for aorta, \>2mm for its branches) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in late mural enhancement (subjective grading) at MRI analysis | at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start) | 0= no mural enhancement; 1. slight mural enhancement; 2. strong mural enhancement and/or perivascular enhancement |
| Change in mural edema (subjective grading) at MRI analysis | at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start) | 0= no mural edema; 1. slight mural edema; 2. strong mural edema |
| Change in dynamic contrast agent uptake in Golden Angle Radial Sparse Parallel MRI (GRASP MRI) | at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start) | Dynamic contrast agent uptake in GRASP will be assessed in areas with wall thickening (grade 1 or 2 as defined above) |
| Change in Apparent Diffusion Coefficient (ADC) as assessed with DW-MRI in absolute numbers (in mm2/s) | at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start) | Apparent Diffusion Coefficient (ADC) as assessed with DW-MRI in absolute numbers (in mm2/s) |
| Change in Standard value uptake measurement (SUV) based on quantitative score normalized to liver (SUV vessel max/liver mean) at PET/CT analysis | at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start) | Standard value uptake measurement (SUV) based on quantitative score normalized to liver (SUV vessel max/liver mean) |
Countries
Switzerland
Outcome results
None listed