Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 149
- 试验地点
- 7
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suspected of PMR seen at the Department of Rheumatology/internal medicine in Aarhus, Silkeborg, Horsens, Gødstrup, Randers, and Svendborg.
- •Proximal extremity pain.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: Baseline
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.
A clinical diagnosis of PMR at baseline and a negative PET not requiring glucocorticoids for more than 3 months during the first year.
时间窗: Baseline to 1 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.
次要结局
- 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)
- 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)
- Extra-capsular PMR and remission after 2 or 4 weeks.(Baseline to 4 weeks)
- Extra-capsular PMR with relapse and remaining in prednisolone treatment within the first year, first 3 years, and first 5 years.(Baseline to 5 years)
- Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/CT after 8 weeks of prednisolone treatment, with MRI findings used to support PET interpretation.(8 weeks)
- Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on MRI findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.(Baseline to 5 years)
- Clinical diagnosis of PMR after 1 year and a positive [18F]FDG-PET/MRI after 8 weeks of prednisolone treatment.(8 weeks)
- Clinical diagnosis of PMR after 1 year and a positive MRI after 8 weeks of prednisolone treatment.(8 weeks)
- Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on [18F]FDG-PET/MRI findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.(Baseline to 5 years)
- Specific baseline clinical information and baseline, 8 weeks, or changes after 8 weeks of prednisolone treatment on ultrasonography findings, and the prediction of relapse and prednisolone-free remission after 1 year, 3 years, and 5 years.(Baseline to 5 years)
- Baseline characteristics for patients with a positive PET scan and a clinical diagnosis of PMR at baseline.(Baseline)
- Baseline MRI findings for patients with a positive PET scan and a clinical diagnosis of PMR at baseline.(Baseline)
- Baseline characteristics for patients with a clinical diagnosis of PMR at baseline and a negative PET scan not receiving glucocorticoids for more than 3 months during the first year.(Baseline to 1 year)
- Clinical diagnosis of PMR after 1 year and symptomatic or asymptomatic (subclinical) GCA at diagnosis, week 8, year 1, year 3, and year 5 in patients diagnosed with PMR.(Baseline to 5 years)
- Clinical diagnosis of PMR after 1 year and positive ultrasound findings around the shoulders and hips at baseline, week 8, year 1, year 3, and year 5.(Baseline to 5 years)
- Physical activity evaluated with step count using the physical activity tracking application over the course of one year in patients with PMR.(Baseline to 1 year)
- Decreased physical activity during doctor-diagnosed relapses of PMR.(Baseline to 1 year)
- Fulfilling the criteria for fibromyalgia at baseline and after 1, 3, and 5 years.(Baseline to 5 years)
研究者
Kresten Krarup Keller
Associate professor
Aarhus University Hospital