Clinical trial NCT04204876: Longitudinal Imaging in Patients With Large Vessel Vasculitis to Predict Further Disease Course
Official title: Longitudinal Imaging in Patients With Large Vessel Vasculitis to Predict Further Disease Course
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Giant Cell Arteritis
Large Vessel Giant Cell Arteriitis
Keywords: magnet resonance imaging (MRI)
Positron emission tomography/computer tomography (PET/CT)
GCA relapse
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss Foundation for the Study of Muscular Diseases
First posted: 2019-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in mural thickening at MRI analysis
timeFrame: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)
Secondary outcomes:
measure: Change in late mural enhancement (subjective grading) at MRI analysis
timeFrame: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)
measure: Change in mural edema (subjective grading) at MRI analysis
timeFrame: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)
measure: Change in dynamic contrast agent uptake in Golden Angle Radial Sparse Parallel MRI (GRASP MRI)
timeFrame: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)
measure: Change in Apparent Diffusion Coefficient (ADC) as assessed with DW-MRI in absolute numbers (in mm2/s)
timeFrame: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)
measure: Change in Standard value uptake measurement (SUV) based on quantitative score normalized to liver (SUV vessel max/liver mean) at PET/CT analysis
timeFrame: at time of diagnosis of GCA and before treatment stop (in order 52 weeks after treatment start)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Rheumatology, University Hospital Basel
Study officials:
affiliation: Department of Rheumatology, University Hospital Basel
name: Thomas Daikeler, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
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