Longitudinal Imaging in Patients With Large Vessel Vasculitis to Predict Further Disease Course

Completed

• Conditions: Large Vessel Giant Cell Arteriitis; Giant Cell Arteritis
• Interventions: Diagnostic Test: Magnet Resonance Imaging (MRI); Diagnostic Test: PET/CT analysis

• Registration Number: NCT04204876
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Study Start: 2020-05-28
• Primary Completion: 2023-08-05
• Study Completion: 2023-08-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with GCA	Magnet Resonance Imaging (MRI)	All patients presenting with a new diagnosis of LV-GCA and all patients already treated for LV-GCA and planned for treatment termination
patients with GCA	PET/CT analysis	All patients presenting with a new diagnosis of LV-GCA and all patients already treated for LV-GCA and planned for treatment termination

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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)

Trial Locations

Locations (1)

Department of Rheumatology, University Hospital Basel; 🇨🇭 Basel, Switzerland