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

NCT ID: NCT04650867

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2022-12-20

Brief Summary

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

Detailed Description

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.

Conditions

Crohn's Disease; Ulcerative Colitis; IBD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with Crohn's disease

Patients diagnosed or with suspected Crohn's disease.

Multispectral Optoacoustic Tomography (MSOT)

Intervention Type: DEVICE

Non-invasive transcutaneous MSOT imaging of the bowel wall (terminal ileum, ascending caecum/colon, transverse colon, descending colon, and sigmoid colon).

Patients with Ulcerative colitis

Patients diagnosed or with suspected Ulcerative colitis

Multispectral Optoacoustic Tomography (MSOT)

Intervention Type: DEVICE

Non-invasive transcutaneous MSOT imaging of the bowel wall (terminal ileum, ascending caecum/colon, transverse colon, descending colon, and sigmoid colon).

Patients with unclassified inflammatory bowel disease (U-IBD)

Patients diagnosed or with suspected unclassified inflammatory bowel disease (U-IBD)

Multispectral Optoacoustic Tomography (MSOT)

Intervention Type: DEVICE

Non-invasive transcutaneous MSOT imaging of the bowel wall (terminal ileum, ascending caecum/colon, transverse colon, descending colon, and sigmoid colon).

Interventions

Multispectral Optoacoustic Tomography (MSOT)

Non-invasive transcutaneous MSOT imaging of the bowel wall (terminal ileum, ascending caecum/colon, transverse colon, descending colon, and sigmoid colon).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. CD patients

• Diagnosis CD or suspected CD at initial diagnosis
• Indication for endoscopy and sampling (biopsy)

2. UC patients

• Diagnosis UC or suspected UC at initial diagnosis
• Indication for endoscopy and sampling (biopsy)

3. 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ferdinand Knieling, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatric- and Adolescent Medicine, FAU Erlangen-Nürneberg

Locations

University Hospital Erlangen

Erlangen, Bavaria, Germany

Countries

Germany

References

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Other Identifiers

351_20B

Identifier Type: -

Identifier Source: org_study_id