Comparison of Sodium Fluoride Positron Emission Tomography and Magnetic Resonance Imaging of Spine and Sacroiliac Joints for Detection of Inflammatory Lesions in Patients Affected by Spondyloarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Concordance between semi-quantitative evaluation of bone inflammation in MRI data and PET data
研究概览
简要总结
The purpose is to compare detection of axial inflammatory lesions in patients affected by spondyloarthritis (SpA) with sodium fluoride positron emission tomography (PET) and magnetic resonance imaging (MRI), the reference technique.
It would be interesting to show the superiority of sodium fluoride PET on MRI for diagnosis of inflammatory lesions. It could be used for diagnostic care but also therapeutic care of patients with early forms of spondyloarthritis.
Secondary purposes are:
- To evaluate performances of sodium fluoride PET in detection of SpA peripheral damage (except spine and sacroiliac joints)
- To evaluate bone inflammation (axial and peripheral) with sodium fluoride PET and compare these data to clinic-biologic parameters used in clinical practice (BASDAI, BASFI, BASMI, sedimentation rate, C-reactive protein (CRP)) and to structural evaluation (sacroiliac New York, mSASSS and BASRI scoring methods)
- To study correlation of axial and peripheral bone inflammation (spine and sacroiliac joints) evaluated with sodium fluoride PET with biologic markers of inflammation and bone remodeling (MMP-3; DKK-1, IL-6, IL-17, TNF-α).
Known biologic markers of inflammation in SpA are correlated to activity obtained with MRI. It is interesting to compare to activity obtained with PET. Moreover, it has been recently showed the disassociation of inflammation and structural progression (anti-TNF treatments do not prevent structural progression) that is associated to markers of bone remodeling whose activity is influenced by an activation/inhibition system of biologic markers of inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-50 year-old patients affected by axial or mixed SpA (ASAS criteria) or >18 year-old patients according to New York criteria
- •Patients with bone marrow edema lesions in sacroiliac joints and/or spine detected with MRI
- •No therapeutic changes between hospitalization for evaluation of SpA activity and inclusion visit
- •Informed consent
- •Affiliation to social security plan
排除标准
- •Refusal or impossibility of signed informed consent
- •Doubt about possible pregnancy in women of childbearing potential
- •Pregnancy and breastfeeding
- •History of drug addiction, alcoholism, psychological problems, severe co-morbidities
- •Renal insufficiency (creatinine clearance < 60 ml/min)
- •Juridical protection
研究组 & 干预措施
Spondyloarthritis Patients
干预措施: Magnetic Resonance Imaging (Other)
Spondyloarthritis Patients
干预措施: Sodium fluoride Positron Emission Tomography (Procedure)
Spondyloarthritis Patients
干预措施: Radiography (Other)
Spondyloarthritis Patients
干预措施: Blood sample (Other)
结局指标
主要结局
Concordance between semi-quantitative evaluation of bone inflammation in MRI data and PET data
时间窗: up to 4 weeks
PET: BME score adapted to PET for spine and modified SPARCC score adapted to PET for sacroiliac joints MRI: Berlin score BME for spine and SPARCC score for sacroiliac joints
Concordance between binary topographic evaluations of bone inflammation in PET data and MRI data
时间窗: up to 4 weeks
presence or absence of inflammatory sites (MRI) or hyperfixation (PET) in 28 sites (24 vertebrae and 4 sacroiliac joints)
次要结局
- Structural evaluation with mSASSS scores(day 0)
- Evaluation of spinal mobility with BASMI index(up to 4 weeks)
- Evaluation of functional impact with BASFI index(up to 4 weeks)
- Structural evaluation with New York score(day 0)
- Standard biologic evaluation of sedimentation rate(day 0)
- Structural evaluation with BASRI score(day 0)
- Levels of specific biologic markers of inflammation and bone remodeling in blood(up to 4 weeks)
- Evaluation of disease activity with BASDAI index(up to 4 weeks)
- Standard biologic evaluation of C-reactive protein(day 0)