Performance of Non-injected MR Enterography Compared to a Conventional MR Enterography Protocol With Contrast Agent Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Presence or absence of lesions detected visually by a radiologist on injection-free sequences versus conventional MR enterography.
研究概览
简要总结
Entero-MRI is indicated in Crohn's disease as part of the initial work-up or follow-up (to assess response to treatment, complications). The protocol for carrying out the examination complies with precise specifications set out in international recommendations. To perform the test, the small intestine must be distended with a hyperosmolar product. This protocol is applied to all patients, with no distinction or adaptation.
The total duration of the examination is sometimes difficult for patients to bear. Ingestion of the product to obtain distension of the small intestine is often poorly tolerated by patients.
In a number of cases, the entero-MRI may have been normal due to symptomatology regression or other diagnosis. The patient therefore underwent a complete examination similar to that of a patient with a pathology requiring characterization.
In this context, the investigators hypothesize that fast MR sequences are sufficient to discriminate between normal and abnormal examinations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patient with MR enterography examination for follow-up or suspected Crohn's disease
排除标准
- 未提供
研究组 & 干预措施
Patients with Crohn's disease or suspected Crohn's disease
干预措施: MRI (Device)
结局指标
主要结局
Presence or absence of lesions detected visually by a radiologist on injection-free sequences versus conventional MR enterography.
时间窗: Baseline (day 0)
次要结局
未报告次要终点
研究者
Valérie LAURENT
Principal Investigator
Central Hospital, Nancy, France
