Using PET and MRI scans to improve diagnosis and treatment of polymyalgia rheumatica
Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica
This project will try combined PET/CT and PET/MRI scans to see if they improve diagnosis and treatment choices for people over 50 with suspected polymyalgia rheumatica.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 149 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 7 sites (Aarhus and 6 other locations) |
| Trial ID | NCT07010484 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults over 50 with new-onset proximal extremity pain suspected of PMR who have not used glucocorticoids recently and can undergo PET/MRI are the intended participants.
Not a fit: Patients with recent glucocorticoid treatment, symptom duration over one year, other known inflammatory rheumatic diseases, suspected giant cell arteritis, recent active cancer, or MRI contraindications are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could reduce unnecessary steroid exposure by improving diagnostic accuracy and thereby lower prednisolone-related side effects.
How similar studies have performed: PET/CT has been used in PMR with mixed diagnostic accuracy and combining MRI to inform PET interpretation is a relatively novel approach with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aarhus and 6 other locations
- Aarhus University Hospital — Aarhus, 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)
- Central Jutland Regional Hospital — Silkeborg, Denmark (Recruiting)
- Svendborg Hospital — Svendborg, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.