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
- 否
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
研究点 (2)
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