Monitoring of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography

NCT06107179 | Unknown

• 1 other identifier: 23-278-Bm
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

Keywords

MSOT; Optoacoustics; Photoacoustics

Outcome Measures

Primary Outcomes (1)

• MSOT signal for hemoglobin in the intestinal wall of participants

  Longitudinal analysis of MSOT signal for oxygenated and deoxygenated hemoglobin in the intestinal wall of children and adolescents with CD and UC.

  6 - 12 months

Secondary Outcomes (12)

• 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 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 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

• Quantitative amount of single wavelength signal in a.u.

  6 - 12 months

• Optoacoustic spectrum in a.u

  6 - 12 months

Study Arms (2)

Crohns Disease

Patients with Crohns Disease

Diagnostic Test: Multispectral Optoacoustic Tomography

Ulcerative Colitis

Patients with Ulcerative Colitis

Diagnostic Test: Multispectral Optoacoustic Tomography

Interventions

Multispectral Optoacoustic Tomography DIAGNOSTIC_TEST

In MSOT, laser light is emitted into the target tissue via a handheld probe. Thermoelastic expansion of various molecules in the target area generates ultrasound waves that are detected by the transducer. The detected signals are reconstructed into images using algorithms. Spectral analysis of the optoacoustic signal at different wavelengths in the near-infrared range can detect individual chromophores, such as oxygenated and deoxygenated hemoglobin.

Crohns Disease; Ulcerative Colitis

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

IBD patients will be enrolled from the department of pediatric gastroenterology of the University hospital Erlangen, a primary care clinic

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Nursing mothers
• Cardiopulmonary unstable patients\*: Need for continuous cardiopulmonary monitoring
• Tattoo in the area of the examination field
• Subcutaneous fat \> 3 cm

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Adrian P Regensburger

  Childrens Hospital of the University hospital of Erlangen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian P Regensburger, MD

CONTACT

+49 91318541151; adrian.regensburger@uk-erlangen.de

Ferdinand Knieling, MD

CONTACT

ferdinand.knieling@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: January 24, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 14, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)