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

Recruitingn/aAges 50 Years - anyAllKresten Krarup Keller
NCT07010484 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients suspected of PMR seen at the Department of Rheumatology/internal medicine in Aarhus, Silkeborg, Horsens, Gødstrup, Randers, and Svendborg. 2. Age above 50. 3. Proximal extremity pain. Exclusion Criteria: 1. Oral, intravenous, intra-articular or intramuscular glucocorticoids within the last 2 months. 2. Previous prednisolone treatment for GCA/PMR. 3. Unable to give consent. 4. Proximal extremity pain duration for more than one year. 5. Symptoms of GCA (headache, scalp tenderness, jaw or tongue claudication, vision disturbances attributable to GCA, limb claudication). 6. Active malignant cancers within the last 5 years (except basal cell carcinoma). 7. Other known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritis, gout). 8. Uncontrolled diseases (e.g. severe active asthma, cardiac disease with NYHA class IV) 9. For MRI: Implants contraindicating MRI and BMI\>150 kg.
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What it tests

  • PET/MRI
  • PET/CT with 18-FDG
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Where

7 sites
Aarhus University Hospital
Aarhus, Denmark
Gødstrup Hospital
Gødstrup, Denmark
Horsens Regional Hospital
Horsens, Denmark
Odense University Hospital
Odense, Denmark
Randers Regional Hospital
Randers, Denmark
Central Jutland Regional Hospital
Silkeborg, Denmark
Svendborg Hospital
Svendborg, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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