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

NCT07010484 | Recruiting

• 2 other identifiers: 1-10-72-69-25NNF24OC0094827
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Polymyalgia Rheumatica (PMR)

Keywords

polymyalgia rheumatica; imaging; diagnosis; PET/CT; PET/MRI

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline

• 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.

  Baseline to 1 year

Secondary Outcomes (21)

• Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI at baseline.

  Baseline

• Clinical diagnosis of PMR after 1 year and a positive MRI at baseline.

  Baseline

• 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.

  Baseline

• Clinical diagnosis of PMR after 1 year and synovitis, bursitis, and tendinitis/tenosynovits in the shoulders and hips.

  Baseline

• Clinical diagnosis of PMR after 1 year and extra-capsular PMR diagnosed using [18F]FDG-PET/MRI.

  Baseline

Study Arms (1)

Patients with and suspected of polymyalgia rheumatica

The study 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 polymyalgia rheumatica (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 (estimated 64 from the 111 patients with suspected PMR, and additionally 38 diagnosed with PMR of which approximately 34 will have PMR without concurrent giant cell arteritis). Patients with a clinical diagnosis of PMR and a negative PET will not be started in routine treatment, but receive intramuscular glucocorticoids, which can be followed by oral prednisolone 15 mg tapered during a maximum of 3 month after diagnosis at discretion of the investigator.

Diagnostic Test: PET/MRI; Diagnostic Test: PET/CT with 18-FDG

Interventions

PET/MRI DIAGNOSTIC_TEST

PET/MRI at baseline and week 8

Patients with and suspected of polymyalgia rheumatica

PET/CT with 18-FDG DIAGNOSTIC_TEST

PET/CT in patients not receiving PET/MRI

Patients with and suspected of polymyalgia rheumatica

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suspected of and diagnosed with polymyalgia rheumatica are included.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Symptoms of GCA (headache, scalp tenderness, jaw or tongue claudication, vision disturbances attributable to GCA, limb claudication).
• Active malignant cancers within the last 5 years (except basal cell carcinoma).
• Other known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritis, gout).
• Uncontrolled diseases (e.g. severe active asthma, cardiac disease with NYHA class IV)
• For MRI: Implants contraindicating MRI and BMI\>150 kg.

Sponsors & Collaborators

• Kresten Krarup Keller: lead
• Randers Regional Hospital: collaborator
• Central Jutland Regional Hospital: collaborator
• Gødstrup Hospital: collaborator
• Svendborg Hospital: collaborator
• Odense University Hospital: collaborator
• Regionshospitalet Horsens: collaborator

Study Sites (7)

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma.

MeSH Terms

Conditions

Polymyalgia Rheumatica; Disease

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Kresten K Keller, MD, PhD

  Department of Rheumatology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kresten K Keller, MD, PhD

CONTACT

+45 40384984; krekel@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2032
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication, and 2 years.
• Access Criteria: By resonably request.

Locations

DK (7)