NCT02985424

Polymyalgia Rheumatica and Giant Cell Arteritis

Polymyalgia Rheumatica and Giant Cell Arteritis - Three Challenges - Consequences of the Vasculitis Process, Osteoporosis and Malignancy: A Prospective Cohort Study Protocol

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Svendborg Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis pattern of the large vessels (PET positivity) and the clinical picture of Polymyalgia Rheumatica (PMR)/Giant Cell Arteritis (GCA) .

Detailed description

Introduction: Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA) are common inflammatory conditions. The diagnosis of PMR/GCA poses many challenges since there are no specific diagnostic tests. Recent literature emphasizes the ability of 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) to assess global disease activity and/or inflammation burden. 18F-FDG PET/CT may lead to make diagnosis at an earlier stage than conventional imaging and assess response to therapy. With respect to the management of PMR/GCA, there are three significant areas of concern as follows: Vasculitis process/vascular stiffness, malignancy and osteoporosis. Methods and Analysis: Patients: All patients with the suspicion of PMR/GCR will be offered to participate in the study. The current protocol consists of 4 separate studies including: I) The association of clinical picture of PMR/GCA with PET detected vasculitis II) Evaluating validity of 18F-FDG PET/CT scan for diagnosis of PMR/GCA compared to temporal artery biopsy III) Incidence of new diagnosed malignancies in patients with PMR/GCA, or PMR like syndrome with the aim of PET/CT scan and Chest X ray/Abdominal ultrasound IV) Impact of disease process as well as steroid treatment on bone mineral density, body composition and vasculitis/vascular stiffness in PMR/GCA patients.

Conditions

• Polymyalgia Rheumatica
• Giant Cell Arteritis

Interventions

Type	Name	Description
OTHER	18F-FDG PET/CT	18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-02-01
• Completion: 2020-02-01
• First posted: 2016-12-07
• Last updated: 2017-04-25

Locations

1 site across 1 country: Denmark