MRI in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Inflammation changes in gastrointestinal tract in MRI.
研究概览
简要总结
The aim of this study is to find an optimal magnetic resonance imaging (MRI) method to examine patients with inflammatory bowel disease (IBD). Patients should furthermore avoid being exposed to unnecessary X-rays and invasive examination.
It is the investigators expectation that this study will benefit to future patients, as they will be offered MRI as the first choice. Hereby, the patients avoid the risks and discomfort associated with x-ray examinations. The aim is that patients with IBD achieve better and earlier treatment and if this is achieved it both benefits patient and public health. An earlier treatment leads to fewer hospitalizations and thereby saving the community money.
The investigators hope is that the investigators study will show that MRI is one of the best tool to examine patients with IBD and that this in future leads MRI to be the first choice in contrary to all examinations with x-ray exposer, unless there is any contraindication to MRI.
详细描述
IBD is a common term for two chronic diseases, Crohn's disease (CD) and ulcerative colitis (UC). IBD occurs often between the ages of 20-30 years. There are about 25,000 people in Denmark with IBD and diseases incidence and prevalence has increased over the past 20 years [1]. In Denmark, the incidence of CD increased fourfold to 10 per 100,000 inhabitants per years and the incidence of UC doubled to 17 per 100,000 inhabitants per years [2]. Its causes are not completely known but it indicates an interaction between genetic and external factors.
IBD as mentions is a chronic disease which means that it flare up periodically throughout life. Studies show that about 50% at a given time is in clinical remission, 25% had moderate disease activity and 25% have significant disease activity [3]. This means that patients with IBD are more likely to undergo repeatedly examinations to confirm or invalidate disease activity. It is essential for patients that the disease is kept under control so they can maintain a normal working life and a well-functioning social life.
Most studies as when the investigators study began have been in the form of conventional small-bowel follow-through and computed tomographic (CT). A few places in Denmark are beginning to experiment with MRI diagnostics but the method has still no standardized protocol.
There are many advantages by using MRI:
Patients avoid being exposed to X-ray radiation and thus the examination can be carried out repeatedly without any problems. It is especially important for fertile women.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •patients with known or suspected IBD
- •age > 18 years
排除标准
- •age < 18 years
- •low kidney function (eGFR < 30)
- •contraindication for MRI (pacemaker, metal in the body, claustrophobia)
- •severe illness
- •pregnancy/lactation
结局指标
主要结局
Inflammation changes in gastrointestinal tract in MRI.
时间窗: 1 day
Observe the inflammatory changes in bowel.
evaluate MRI using faecal calprotectin (fC) as a reference standard.
时间窗: 1-3 days
MRI is evaluated and fC is received about 3 day after MRI.
次要结局
未报告次要终点