Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorKresten Krarup Keller

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • PET/MRI

    Diagnostic test

    PET/MRI at baseline and week 8

  • PET/CT with 18-FDG

    Diagnostic test

    PET/CT in patients not receiving PET/MRI

Treatment groups

149 Participants
are divided into 1 treatment group
Group A: Patients with and suspected of polymyalgia rheumatica2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline to 1 year

Secondary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline
4

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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