跳至主要内容
临床试验/NCT06526234
NCT06526234已完成不适用

Performance of Non-injected MR Enterography Compared to a Conventional MR Enterography Protocol With Contrast Agent Injection

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

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

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

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Valérie LAURENT

Principal Investigator

Central Hospital, Nancy, France

研究点 (1)

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