跳至主要内容
临床试验/NCT03345355
NCT03345355终止不适用

MRI of Sacroiliac Joints: Evaluation of Accuracy of Dixon Sequences in the Diagnosis of Axial Spondyloarthritis

Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2018年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
5
试验地点
2
主要终点
Diagnostic performance of T1 Dixon post-Gadolinium and T2 Dixon for active sacroiliitis, according to subchondral edema status

研究概览

简要总结

The investigators hypothesize that the T1 Dixon post-Gadolinium and T2 Dixon sequences will show good diagnostic performances for active sacroiliitis compared to the reference test (Short tau inversion recovery) and clinical-biological criteria, which will allow a better diagnosis of active sacroiliitis

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is at least 18 years old
  • The patient has a clinically diagnosed axial spondyloarthritis (axSpA) (ASAS or AMOR classification)
  • Patient has an active axSpA (BASDAI>4)

排除标准

  • The subject is participating in another study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The patient is pregnant or breastfeeding
  • The patient has a contra-indication

结局指标

主要结局

Diagnostic performance of T1 Dixon post-Gadolinium and T2 Dixon for active sacroiliitis, according to subchondral edema status

时间窗: Time 0

compared to ASAS criteria incorporating Short tau inversion recovery and clinic-biological elements

次要结局

  • Diagnosis of enthesitis from T1 Gadolinium Dixon sequence vs ASAS criteria(Time 0)
  • Diagnosis of synovitis from T2 Dixon and T1 Gadolinium Dixon sequences vs ASAS criteria(Time 0)
  • Diagnosis of chronic sacroiliite (erosion or chondral scler osis, or fatty spinal replacement) by T1 Dixon pre-Gadolinium(Time 0)
  • Diagnosis of chronic sacroiliite (erosion or chondral sclerosis, or fatty spinal replacement) by conventional sequences(Time 0)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (2)

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