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
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
- 是
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
