跳至主要内容
临床试验/NCT05354609
NCT05354609进行中(未招募)不适用

Assessment of Intestinal Inflammatory Activity in the Follow-up of Patients With Crohn's Disease: Diffusion-weighted MR-enterography, Without or With Bowel Cleansing, Compared With Standard MR-enterography

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
140
试验地点
2
主要终点
variation of inflammatory activity localisation number in the main bowel

研究概览

简要总结

Since 2009, many studies tend to prove the effectiveness of diffusion-weighted MR-enterography in the assessment of inflammatory activity in IBD compared to standard MR-enterography, with the emergence of new radiological scores such as the Clermont score. Diffusion-weighted MRI (DWI) is a faster technique and does not require the injection of gadoline contrast medium, which is a desirable in view of recent data on their long-term adverse effects (intracerebral deposits, nephrogenic systemic fibrosis).

The advent of 3T MRI, which provides a better signal, a better spatial resolution or the same examination quality in a shorter time, seems promising for the future of DWI.

However, to date, there are still few studies carried out at 3T in this field or even few studies on the possibility of doing away with bowel cleansing, although this is one of the main demands of patients. All patients will undergo a simplified MR-enterography, which includes four sequences, without bowel cleansing or injection. On the same day, the standard MR-enterography will be performed as in clinical practice, after ingestion of the usual oral preparation.

Three reading sessions of the examination will be organized at intervals of at least one month by two radiologists specialized in digestive imaging, blinded to the clinical and

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

入选标准

  • Any patient diagnosed with Crohn's disease with bowel involvement for whom a MR-enterography was ordered as part of their follow-up
  • Subject's ability to understand and express opposition
  • Affiliation to French social security system

排除标准

  • Any contraindication to MRI
  • Allergy to gadolinium chelates
  • Claustrophobia
  • Major obesity that does not allow the patient to enter the machine's tunnel (whose diameter is 70 cm)
  • Pregnant woman
  • Person under curators or guardianship

结局指标

主要结局

variation of inflammatory activity localisation number in the main bowel

时间窗: one day

variation of inflammatory activity localisation number in the main bowel between diffusion entero-MRI with bowel cleansing versus standard enteroMRI

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验