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

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

Detailed Description
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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.

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

Conditions
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Crohn's Disease, Ulcerative Colitis, IBD

Intervention / Treatment
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* Device: Multispectral Optoacoustic Tomography (MSOT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Crohn's disease<br>Patients diagnosed or with suspected Crohn's disease. | Device: Multispectral Optoacoustic Tomography (MSOT)<br>* Non-invasive transcutaneous MSOT imaging of the bowel wall (terminal ileum, ascending caecum/colon, transverse colon, descending colon, and sigmoid colon).<br>|
| Patients with Ulcerative colitis<br>Patients diagnosed or with suspected Ulcerative colitis | Device: Multispectral Optoacoustic Tomography (MSOT)<br>* Non-invasive transcutaneous MSOT imaging of the bowel wall (terminal ileum, ascending caecum/colon, transverse colon, descending colon, and sigmoid colon).<br>|
| Patients with unclassified inflammatory bowel disease (U-IBD)<br>Patients diagnosed or with suspected unclassified inflammatory bowel disease (U-IBD) | Device: Multispectral Optoacoustic Tomography (MSOT)<br>* Non-invasive transcutaneous MSOT imaging of the bowel wall (terminal ileum, ascending caecum/colon, transverse colon, descending colon, and sigmoid colon).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative amount of oxygenated/deoxygenated hemoglobin in a.u. | 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.) | Single time point (1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative amount of fibrosis/collagen signal in a.u. | fibrosis/collagen signals in the intestinal wall of children with different entities of IBD (CD vs. UC vs. U-IBD) derived by MSOT in arbitrary units (a.u.) | Single time point (1 day) | 
| Quantitative amount of single wavelength signal in a.u. | single wavelength signals in the intestinal wall of children with different entities of IBD (CD vs. UC vs. U-IBD) derived by MSOT in arbitrary units (a.u.) | Single time point (1 day) | 
| Optoacoustic spectrum in a.u. | Optoacoustic spectrum in the intestinal wall of children with different entities of IBD (CD vs. UC vs. U-IBD) derived by MSOT in arbitrary units (a.u.) | Single time point (1 day) | 
| Endoscopic extent of inflammation | Assessment of inflammation in endoscopies within different entities of IBD (CD vs. UC vs. U-IBD) | Single time point (1 day), +/- 7 days from MSOT Imaging | 
| Histological extent of inflammation and fibrosis | Assessment of inflammation and fibrosis in histological samples from biopsies within different entities of IBD (CD vs. UC vs. U-IBD) | Single time point (1 day), +/- 7 days from MSOT Imaging | 
| Clinical evaluation | Assessement of clinical disease status by PCDAI or PUCAI according to the CED within different entities of IBD (CD vs. UC vs. U-IBD) | Single time point (1 day) | 
| Ultrasound | Assessment of disease status by ultrasound within different entities of IBD (CD vs. UC vs. U-IBD) | Single time point (1 day), +/- 1 day from MSOT Imaging | 
| Laboratory parameters (blood - c-reaktive protein (CrP)) | Assessment of disease status by laboratory parameters (CrP) within different entities of IBD (CD vs. UC vs. U-IBD) | Single time point (1 day), +/- 7 day from MSOT Imaging | 
| Laboratory parameters (stool - Calprotectin) | Assessment of disease status by laboratory parameters (Calprotectin) within different entities of IBD (CD vs. UC vs. U-IBD) | Single time point (1 day), +/- 14 day from MSOT Imaging | 
| MRI | Assessment of disease status by MRI (if applicable) within different entities of IBD (CD vs. UC vs. U-IBD) | Single time point (1 day), +/- 14 day from MSOT Imaging | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn Disease, CD, Ulcerative Colitis, MSOT, Crohn's Disease, UC, chronic inflammatory bowel disease, IBD