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

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ClinicalTrials.gov Identifier: NCT04204876
Recruitment Status : Recruiting
First Posted : December 19, 2019
Last Update Posted : September 15, 2022
Sponsor:
Collaborator:
Swiss Foundation for the Study of Muscular Diseases
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  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)

    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 :
  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;

    1. slight mural enhancement;
    2. 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;

    1. slight mural edema;
    2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients presenting with a new diagnosis of LV-GCA and all patients already treated for LV-GCA and planned for treatment termination at the University Hospital Basel.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04204876


Contacts
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Contact: Thomas Daikeler, Prof. Dr. MD +41 61 265 2709 thomas.daikeler@usb.ch
Contact: Bettina Bannert, Dr. med +41 61 556 5017 bettina.bannert@usb.ch

Locations
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Switzerland
Department of Rheumatology, University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Thomas Daikeler, Prof. Dr. MD    +41 61 265 2709    thomas.daikeler@usb.ch   
Contact: Bettina Bannert, Dr. med    +41 61 556 5017    bettina.bannert@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss Foundation for the Study of Muscular Diseases
Investigators
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Principal Investigator: Thomas Daikeler, Prof. Dr. MD Department of Rheumatology, University Hospital Basel
Publications:

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04204876    
Other Study ID Numbers: 2019-02161; me18Daikeler
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: September 15, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University Hospital, Basel, Switzerland:
magnet resonance imaging (MRI)
Positron emission tomography/computer tomography (PET/CT)
GCA relapse
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Vasculitis
Arteritis
Disease Progression
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Disease Attributes
Pathologic Processes