Using PET and MRI scans to improve diagnosis and treatment of polymyalgia rheumatica

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study enrolls patients over 50 with new proximal limb pain suspected of PMR and uses 18F-FDG PET/CT and PET/MRI to compare imaging interpretation with and without MRI guidance. Imaging will be performed at baseline and again after 8 weeks of prednisolone in a cohort of 111 suspected cases to see how steroid treatment affects diagnostic signal. A separate group of 100 newly diagnosed patients will follow a treatment initiation strategy guided by clinical diagnosis combined with PET results. The observational study is conducted across several regional Danish hospitals and excludes patients with recent glucocorticoid use, other inflammatory rheumatic diseases, suspected giant cell arteritis, active recent cancer, or MRI contraindications.

Why it matters

Who can join: the full rules

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.

Where it's running

• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Central Jutland Regional Hospital
  Silkeborg, Denmark Recruiting
• Gødstrup Hospital
  Gødstrup, Denmark Not yet recruiting
• Horsens Regional Hospital
  Horsens, Denmark Not yet recruiting
• Odense University Hospital
  Odense, Denmark Not yet recruiting
• Randers Regional Hospital
  Randers, Denmark Not yet recruiting

Study contacts

• Principal investigator: Kresten K Keller, MD, PhD — Department of Rheumatology, Aarhus University Hospital
• Study coordinator: Kresten K Keller, MD, PhD
• Email: krekel@rm.dk
• Phone: +45 40384984

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.