Monitoring of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography

Ulcerative Colitis Clinical Trial

Official title:

Non-invasive Monitoring of Disease Activity in Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06107179
• Other study ID #: 23-278-Bm
• Status: Recruiting
• Start date: January 24, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: October 2023
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Adrian P Regensburger, MD
• Phone: +49 91318541151
• Email: adrian.regensburger[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnancy

• Nursing mothers

• Cardiopulmonary unstable patients*: Need for continuous cardiopulmonary monitoring

• Tattoo in the area of the examination field

• Subcutaneous fat > 3 cm

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Diagnostic Test:
• Multispectral Optoacoustic Tomography
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.

Locations

Country	Name	City	State
Germany	University Hospital Erlangen	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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
Secondary	Quantitative comparison of oxygenated and deoxygenated hemoglobin signal measured by MSOT in different intestinal wall sections of children and adolescents with CD and UC.	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
Secondary	-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)	-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
Secondary	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) derived by MSOT in arbitrary units (a.u.)	6 - 12 months
Secondary	Optoacoustic spectrum in a.u	Optoacoustic spectrum in the intestinal wall of children with different entities of IBD (CD vs. UC) derived by MSOT in arbitrary units (a.u.)	6 - 12 months
Secondary	Endoscopic extent of inflammation (if applicable)	Assessment of inflammation in endoscopies within different entities of IBD (CD vs. UC)	6 - 12 months
Secondary	Histological extent of inflammation and fibrosis (if applicable)	Assessment of inflammation and fibrosis in histological samples from biopsies within different entities of IBD (CD vs. UC)	6 - 12 months
Secondary	Clinical evaluation	Assessement of clinical disease status by PCDAI or PUCAI according to the CED within different entities of IBD (CD vs. UC)	6 - 12 months
Secondary	Ultrasound	Assessment of disease status by ultrasound within different entities of IBD (CD vs. UC)	6 - 12 months
Secondary	Laboratory parameters (blood - c-reactive protein (CrP)) (if applicable)	Assessment of disease status by laboratory parameters (CrP) within different entities of IBD (CD vs. UC)	6 - 12 months
Secondary	Laboratory parameters (stool - Calprotectin) (if applicable)	Assessment of disease status by laboratory parameters (Calprotectin) within different entities of IBD (CD vs. UC)	6 - 12 months
Secondary	MRI (if applicable)	Assessment of disease status by MRI within different entities of IBD (CD vs. UC)	6 - 12 months