Monitoring of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06107179

Collaborator

(none)

Enrollment

26.1

Anticipated Duration (Months)

Study Details

Study Description

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 charakterize 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 recieve therapy? Participants will be examined with multispectral optoacoustic tomography.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease Ulcerative Colitis Inflammatory Bowel Diseases	Diagnostic Test: Multispectral Optoacoustic Tomography

Detailed 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. We 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Crohns Disease Patients with Crohns Disease	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.
Ulcerative Colitis Patients with Ulcerative Colitis	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.

Arm

Intervention/Treatment

Crohns Disease

Patients with Crohns Disease

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.

Ulcerative Colitis

Patients with Ulcerative Colitis

Diagnostic Test: Multispectral Optoacoustic Tomography

Outcome Measures

Primary Outcome Measures

MSOT signal for hemoglobin in the intestinal wall of participants [6 - 12 months]
Longitudinal analsis of MSOT signal for oxygenated and deoxygenated hemoglobin in the intestinal wall of children and adolescents with CD and UC.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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