Non-invasive Monitoring of Disease Activity in Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- MSOT signal for hemoglobin in the intestinal wall of participants
研究概览
简要总结
In this clinical trial, the intestinal wall of pediatric patients with Crohns disease and Ulcerative Colitis will be assessed with multispectral optoacoustic tomography (MSOT) to characterize the optoacoustic signal of the intestinal wall and to monitor disease activity.
The goal of this clinical trial is to compare the optoacoustic signal in the intestinal wall of children with inflammatory bowel diseases. The main questions it aims to answer are:
- How does the optoacoustic signal in children with inflammatory bowel diseases change over time?
- How does the optoacoustic signal in children with inflammatory bowel diseases change when they receive therapy? Participants will be examined with multispectral optoacoustic tomography.
详细描述
In this study, the disease activity of children and adolescents with inflammatory bowel disease (IBD) will be assessed non-invasively by multispectral optoacoustic tomography (MSOT). IBDs play an important role in pediatric and adolescent medicine. The most common entities in the IBS group are Crohn's disease (CD) and ulcerative colitis (UC). Patients with CD develop chronic intermittent transmural inflammation of the gastrointestinal (GI) tract. Symptoms include diarrhea, hematochezia, abdominal pain, and malnutrition. Complications of the disease include fistula formation, perforations, and bleeding.The basis for many clinical decisions is the detection of disease activity.There are limitations to previous imaging methods for routine monitoring that are particularly relevant in pediatric and adolescent medicine.The use of contrast media, sedation, and invasive procedures are a burden for pediatric patients*.Multispectral optoacoustic tomography (MSOT) offers a radiation-free and noninvasive alternative for detecting disease activity. Quantitative assessment of hemoglobin signal in the bowel wall of patients with CD could previously be correlated with endoscopically detected disease activity. The aim of this study is to evaluate whether MSOT also allows monitoring of chronic inflammatory diseases in children. For this purpose, children in different stages of disease who regularly receive intravenous therapeutic administrations of biologics (e.g. infliximab) in our hospital will be examined. The investigators think that by means of MSOT different stages and courses of the diseases could be measured non-invasively and thus invasive measures in children could be reduced.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Existing diagnosis of CD or UC, or suspected CD or UC at initial diagnosis.
- •Age 2 - 18 years
- •Written declaration of consent from parents / legal guardians
排除标准
- •Pregnancy
- •Nursing mothers
- •Cardiopulmonary unstable patients*: Need for continuous cardiopulmonary monitoring
- •Tattoo in the area of the examination field
- •Subcutaneous fat > 3 cm
结局指标
主要结局
MSOT signal for hemoglobin in the intestinal wall of participants
时间窗: 6 - 12 months
Longitudinal analysis of MSOT signal for oxygenated and deoxygenated hemoglobin in the intestinal wall of children and adolescents with CD and UC.
次要结局
- Laboratory parameters (blood - c-reactive protein (CrP)) (if applicable)(6 - 12 months)
- Endoscopic extent of inflammation (if applicable)(6 - 12 months)
- Laboratory parameters (stool - Calprotectin) (if applicable)(6 - 12 months)
- Clinical evaluation(6 - 12 months)
- Quantitative comparison of oxygenated and deoxygenated hemoglobin signal measured by MSOT in different intestinal wall sections of children and adolescents with CD and UC.(6 - 12 months)
- Quantitative comparison of the signal of oxygenated and deoxygenated hemoglobin measured by MSOT in inflamed and non-inflamed intestinal wall sections of children and adolescents with CD and UC.(6 - 12 months)
- -Quantitative comparison of the quantitative fraction of fibrosis/collagen signal determined by MSOT in intestinal walls of children with IBD of different entities (CD and UC)(6 - 12 months)
- Optoacoustic spectrum in a.u(6 - 12 months)
- Ultrasound(6 - 12 months)
- Quantitative amount of single wavelength signal in a.u.(6 - 12 months)
- Histological extent of inflammation and fibrosis (if applicable)(6 - 12 months)
- MRI (if applicable)(6 - 12 months)