About this trial
Polymyalgia rheumatica (PMR) is the most common chronic inflammatory rheumatic disease among the elderly and is characterized by proximal extremity pain and fatigue. Treatment with prednisolone carries several significant adverse effects, and it is therefore essential to avoid unnecessary treatment. However, clinical diagnosis and even imaging such as positron emission tomography and computed tomography (PET/CT) has low diagnostic accuracy, which decrease after start of prednisolone. The purpose is to evaluate a new method to diagnose PMR with PET/CT using magnetic resonance imaging (MRI) for informing the interpretation of PET in 111 patients suspected of PMR at baseline and after 8 weeks prednisolone treatment. In addition, a treatment initiation strategy guided by clinical diagnosis combined with PET will be evaluated in 100 patients with newly diagnosed PMR.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients suspected of PMR seen at the Department of Rheumatology/internal medicine in Aarhus, Silkeborg, Horsens, Gødstrup, Randers, and Svendborg.
Age above 50.
Proximal extremity pain.
Disqualifiers
Oral, intravenous, intra-articular or intramuscular glucocorticoids within the last 2 months.
Previous prednisolone treatment for GCA/PMR.
Unable to give consent.
Proximal extremity pain duration for more than one year.
Trial population
Patients suspected of and diagnosed with polymyalgia rheumatica are included.
Trial design
Cohort
Prospective
Treatments tested in this trial
PET/MRI
Diagnostic testPET/MRI at baseline and week 8
PET/CT with 18-FDG
Diagnostic testPET/CT in patients not receiving PET/MRI
Treatment groups
Trial outcomes
Primary outcomes
Clinical diagnosis of PMR after 1 year and a positive baseline [18F]FDG-PET scan, with MRI findings used to support interpretation of the PET evaluation.
sensitivity and specificity of \[18F\]FDG-PET/CT using PET combined with MRI to inform the interpretation of the PET evaluation, using the clinical diagnosis at 1 year as reference standard.
A clinical diagnosis of PMR at baseline and a negative PET not requiring glucocorticoids for more than 3 months during the first year.
proportion of patients with a positive clinical diagnosis and a negative PET not requiring glucocorticoids for more than 3 months during the first year.
Secondary outcomes
Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI at baseline.
Sensitivity and specificity of \[18F\]FDG-PET/MRI at baseline for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.
Clinical diagnosis of PMR after 1 year and a positive MRI at baseline.
Sensitivity and specificity of MRI at baseline for diagnosing PMR, using the clinical diagnosis at 1 year as reference standard.
Circular, focal, and/or cylindrical [18F]FDG-uptake patterns associated to synovitis, bursitis, and tendinitis/tenosynovitis in the shoulders and hips on MRI or ultrasound.
Investigate if circular, focal and cylindrical \[18F\]FDG-uptake patterns correspond to synovitis, bursitis and tendinitis using MRI and ultrasound for confirmation.
Clinical diagnosis of PMR after 1 year and synovitis, bursitis, and tendinitis/tenosynovits in the shoulders and hips.
Prevalence of synovitis, tendinitis/tenosynovitis and bursitis in PMR and differential diagnoses.
Sponsors and contacts
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Kresten Krarup Keller
Lead sponsor
Aarhus University Hospital
Sponsor institution
Randers Regional Hospital
Collaborator
Central Jutland Regional Hospital
Collaborator
Gødstrup Hospital
Collaborator
Svendborg Hospital
Collaborator
Odense University Hospital
Collaborator
Regionshospitalet Horsens
Collaborator