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临床试验/NCT04650867
NCT04650867已完成不适用

Non Invasive Characterization of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2021年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
1
主要终点
Quantitative amount of oxygenated/deoxygenated hemoglobin in a.u.

研究概览

简要总结

Monocentric, prospective observational study to assess bowel inflammation in children with chronic inflammatory bowel disease (IBD) using multispectral optoacoustic tomography (MSOT).

详细描述

Inflammatory bowel diseases (IBD) play a major role in child and adolescent medicine. 25 % of patients with IBD are younger than 18 years of age at diagnosis and 25 % of those are even younger than 10 years of age at disease onset. The incidence of IBD in children and adolescents is 5-11/100 000 in Germany. IBD comprises mainly two entities, namely Crohn's disease (CD) and ulcerative colitis (UC). Patients with CD develop chronic and intermittent transmural inflammation of the gastrointestinal tract, which manifests with symptoms like diarrhea, hematochezia, abdominal pain, fatigue and malnutrition. This often results in weight loss and an increased risk of numerous complications such as the development of fistulas, perforations and intestinal strictures. In addition, growth disturbances and delayed onset of puberty are more frequent. Overall, the course of the disease can only be compared between children and adults to a very limited extent, as the disease often progresses more rapidly and severely in children. Accordingly, the procedure and recommendations for children with CD differ from those of adults. In addition to clinical scores, laboratory chemical parameters (blood count, CrP, calprotectin) and imaging diagnostics (endoscopy, ultrasound, MRT) are available to assess disease activity. However, the latter are only of limited use for routine monitoring due to their invasiveness, the need for sedation and the use of contrast agents. Multispectral Optoacoustic Tomograph (MSOT) on the other hand allows, comparable to sonography, a non-invasive, quantitative imaging of the composition of target tissues in children without sedation. Previous studies have shown that the quantitative determination of hemoglobin provides information on blood flow and inflammatory activity in the bowel of adult patients with Crohn's disease. In this pilot study, the intestinal wall of children will be characterized by MSOT to differentiate between CD, UC, and unclassified inflammatory bowel disease (U-IBD) and to quantify changes and correlate them with routine parameters. This could lead to a new possibility of non-invasive evaluation of disease forms and activity comparable to previous findings in adult patients with CD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

入选标准

  • CD patients
  • Diagnosis CD or suspected CD at initial diagnosis
  • Indication for endoscopy and sampling (biopsy)
  • UC patients
  • Diagnosis UC or suspected UC at initial diagnosis
  • Indication for endoscopy and sampling (biopsy)
  • U-IBD patients
  • Diagnosis U-IBD or suspected IBD at initial diagnosis
  • Indication for endoscopy and sampling (biopsy)

排除标准

  • Pregnancy
  • Nursing mothers
  • Unstable patients: Need for continuous cardiopulmonary monitoring (ECG and pulse oximetry)
  • Tattoo in the field of investigation
  • Subcutaneous fat tissue over 3 cm
  • Lack of written consent

结局指标

主要结局

Quantitative amount of oxygenated/deoxygenated hemoglobin in a.u.

时间窗: Single time point (1 day)

Oxygenated/deoxygenated hemoglobin signals in the intestinal/bowel wall of children with different entities of IBD (CD vs. UC vs. U-IBD) derived by MSOT in arbitrary units (a.u.)

次要结局

  • Quantitative amount of single wavelength signal in a.u.(Single time point (1 day))
  • Optoacoustic spectrum in a.u.(Single time point (1 day))
  • Endoscopic extent of inflammation(Single time point (1 day), +/- 7 days from MSOT Imaging)
  • Histological extent of inflammation and fibrosis(Single time point (1 day), +/- 7 days from MSOT Imaging)
  • Laboratory parameters (blood - c-reaktive protein (CrP))(Single time point (1 day), +/- 7 day from MSOT Imaging)
  • Clinical evaluation(Single time point (1 day))
  • Laboratory parameters (stool - Calprotectin)(Single time point (1 day), +/- 14 day from MSOT Imaging)
  • MRI(Single time point (1 day), +/- 14 day from MSOT Imaging)
  • Quantitative amount of fibrosis/collagen signal in a.u.(Single time point (1 day))
  • Ultrasound(Single time point (1 day), +/- 1 day from MSOT Imaging)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

研究点 (1)

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