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Completed

NCT Number: NCT04204876

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

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

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Key information

Conditions

Giant Cell Arteritis Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Immune System Diseases Large Vessel Giant Cell Arteriitis Nervous System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Rheumatology, University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnet Resonance Imaging (MRI)

Diagnostic Test

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)

PET/CT analysis

Diagnostic Test

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

Primary outcomes

  1. Change in mural thickening at MRI analysis

    Time frame: 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 outcomes

  1. Change in late mural enhancement (subjective grading) at MRI analysis

    Time frame: 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

  2. Change in mural edema (subjective grading) at MRI analysis

    Time frame: 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

  3. Change in dynamic contrast agent uptake in Golden Angle Radial Sparse Parallel MRI (GRASP MRI)

    Time frame: 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)

  4. Change in Apparent Diffusion Coefficient (ADC) as assessed with DW-MRI in absolute numbers (in mm2/s)

    Time frame: 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)

  5. Change in Standard value uptake measurement (SUV) based on quantitative score normalized to liver (SUV vessel max/liver mean) at PET/CT analysis

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Swiss Foundation for the Study of Muscular Diseases

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 19, 2019
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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