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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT04204876

Collaborator

Swiss Foundation for the Study of Muscular Diseases (Other)

Enrollment

Location

32.2

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Longitudinal imaging in patients with large vessel vasculitis to predict further disease course

Condition or Disease	Intervention/Treatment	Phase
Giant Cell Arteritis Large Vessel Giant Cell Arteriitis	Diagnostic Test: Magnet Resonance Imaging (MRI) Diagnostic Test: PET/CT analysis

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 Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 28, 2020

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
patients with GCA All patients presenting with a new diagnosis of LV-GCA and all patients already treated for LV-GCA and planned for treatment termination	Diagnostic Test: Magnet 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 Test: PET/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

Arm

Intervention/Treatment

patients with GCA

All patients presenting with a new diagnosis of LV-GCA and all patients already treated for LV-GCA and planned for treatment termination

Diagnostic Test: Magnet 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 Test: PET/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

Outcome Measures

Primary Outcome Measures

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) = mural thickening (2-3 mm for aorta, 1-2 mm for its branches); = strong thickening (>3 mm for aorta, >2mm for its branches)

Secondary Outcome Measures

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; slight mural enhancement; 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; slight mural edema; 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.