Accuracy of PET/MRI in Diagnosis and Treatment Evaluation of Children and Adolescents With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Sensitivity, specificity, accuracy and predictive value of PET/MRI at diagnosis of IBD and in differentiating Crohn's disease and Ulcerous colitis.
研究概览
简要总结
The purpose of this study is to test the utility of PET/MRI in diagnosis and management of Inflammatory bowel disease (IBD) in children and adolescents, hereby
- To test if PET/MRI scan is an accurate method to diagnose and differentiate Crohn's disease and Ulcerous Colitis in children and adolescents suspected of IBD.
- To evaluate whether PET/MRI scan in children and adolescents with Crohn's disease is an accurate method to diagnose relapses and to monitor the effect of biological treatment with monoclonal antibodies directed towards Tumor Necrosis Factor-alpha.
详细描述
Crohn's disease and Ulcerous Colitis constitute the primary inflammatory bowel diseases. Crohn's disease can affect any part of the digestive tract, from mouth to anus, and inflammation can be present in all layers of the intestinal wall. Ulcerous Colitis is primarily located in the inner layer of the colonic bowel wall.
In the pediatric population, current diagnostic strategies involve blood tests, fecal sampling (calprotectin), magnetic resonans (MRI) scan and both upper and lower endoscopies. In this population endoscopy requires general anesthesia and involves the risk of bowel wall perforation.
A known method of identifying inflammation is by Positron Emission Tomography (PET). In this procedure a radioactively labelled sugar molecule is injected into the blood stream via a venous catheter. The inflammatory cells take op relatively more of the sugar, compared to normal cells, and the cells are visible on the scan. Until now the anatomic localization of the inflammation has been poor but recently is has become possible to combine the MRI scan with PET resulting in excellent localization, with minimal radiation exposure (corresponding to 1 year background radiation in Denmark).
To make diagnosis and identification of inflammation flares during treatment safer for children and adolescents we aim to investigate whether PET/MRI is accurate in diagnosing IBD in children and adolescents and in diagnosing flares in children with Crohn's disease.
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
- 8 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected of having IBD
- •Planned to undergo standard evaluation OR
- •Known Crohn's disease about to start anti-TNF therapy due to steroid dependency or disease relapse.
排除标准
- •Active or prior diagnosis of inflammatory disease other than IBD
- •Active or prior diagnosis of cancer
- •Type 1 diabetes
- •Not able to lie still for the MRI scan.
结局指标
主要结局
Sensitivity, specificity, accuracy and predictive value of PET/MRI at diagnosis of IBD and in differentiating Crohn's disease and Ulcerous colitis.
时间窗: 6 months
PET/MRI will be compared to standard evaluation: Clinical symptom scoring systems (for Crohns disease: wPCDAI, for Ulcerous colitis: PUCAI), faecal calprotectin, C-reactive protein and endoscopy with histology. Endoscopy will be used for gold reference. PET/MRI scans will be analysed for PET uptake values pr. bowel segment for each patient and compared to standard evaluation results.
Sensitivity, specificity and accuracy of PET/MRI in diagnosing disease flare in Crohn's disease and to evaluate inflammatory response to anti-TNF treatment.
时间窗: 1 month
PET/MRI will be compared to standard evaluation: Clinical symptom scoring systems (wPCDAI), faecal calprotectin, C-reactive protein and endoscopy with histology. The patient will serve as his/her own control. This will be a pilot study. PET/MRI scans will be analysed for PET uptake values pr. bowel segment for each patient and compared to standard evaluation results.
次要结局
未报告次要终点
研究者
Steffen Husby
Professor, MD, DMSc
Odense University Hospital