Comparison of Conventional Clinical and Abbreviated MR Enterography Protocols in Children and Adults With Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Compare clinical MRE with research MRE
研究概览
简要总结
The purpose of our study is to compare an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) protocol to a conventional, standard of care MRE in children and adults with Crohn's Disease.
详细描述
This multi-center study will evaluate the effectiveness of an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) to document the presence and severity of small bowel inflammation, the presence and features of stricturing and penetrating disease in children and adults with Crohn's Disease.
The abbreviated MRI of the bowel or MRE will not involve IV contrast or an injection of glucagon and water will replace the oral contrast used in standard of care MREs. Scan time will be greatly reduced with the abbreviated MRE ( approximately 15 minutes) compared to a standard of care MRE (approximately 60 minutes).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established Crohn's disease diagnosis in patients 10 and older
- •Undergoing clinical magnetic resonance enterography (MRE) examinations for any reason(s) below
- •Staging/ restaging/ follow- up of intestinal inflammation
- •Evaluation of known or suspected luminal narrowing/ stricturing disease
- •Evaluation of known or suspected internal penetrating disease
排除标准
- •Undergoing initial imaging for suspected Crohn's disease where the diagnosis of Crohn's disease has yet to be definitively established
- •New Crohn's disease diagnosis, undergoing baseline imaging
- •Isolated colonic disease
- •Known or suspected pregnancy
- •Contraindication to magnetic resonance imaging (MRI)
- •Ileostomy or prior ileal resection
- •Less than 10 years of age
- •Unable or unwilling to follow imaging procedures
- •Non- English speaking
结局指标
主要结局
Compare clinical MRE with research MRE
时间窗: 3 years
Our abbreviated magnetic resonance enterography (MRE) will be non-inferior to a standard clinical MRE in detecting small bowel inflammation, strictures and penetrating disease associated with Crohn's Disease.
次要结局
- Willingness to trade diagnostic performance for patient experience(3 years)
- Patient experiences and preferences between the abbreviated MRE and the standard clinical MRE.(3 years)