Clinical trial NCT06107179: Monitoring of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography
Official title: Non-invasive Monitoring of Disease Activity in Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn Disease
Ulcerative Colitis
Inflammatory Bowel Diseases
Keywords: MSOT
Optoacoustics
Photoacoustics
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: MSOT signal for hemoglobin in the intestinal wall of participants
timeFrame: 6 - 12 months
Secondary outcomes:
measure: 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.
timeFrame: 6 - 12 months
measure: Quantitative comparison of oxygenated and deoxygenated hemoglobin signal measured by MSOT in different intestinal wall sections of children and adolescents with CD and UC.
timeFrame: 6 - 12 months
measure: -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)
timeFrame: 6 - 12 months
measure: Quantitative amount of single wavelength signal in a.u.
timeFrame: 6 - 12 months
measure: Optoacoustic spectrum in a.u
timeFrame: 6 - 12 months
measure: Endoscopic extent of inflammation (if applicable)
timeFrame: 6 - 12 months
measure: Histological extent of inflammation and fibrosis (if applicable)
timeFrame: 6 - 12 months
measure: Clinical evaluation
timeFrame: 6 - 12 months
measure: Ultrasound
timeFrame: 6 - 12 months
measure: Laboratory parameters (blood - c-reactive protein (CrP)) (if applicable)
timeFrame: 6 - 12 months
measure: Laboratory parameters (stool - Calprotectin) (if applicable)
timeFrame: 6 - 12 months
measure: MRI (if applicable)
timeFrame: 6 - 12 months
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
state: Bavaria
Study officials:
affiliation: Childrens Hospital of the University hospital of Erlangen
name: Adrian P Regensburger
role: PRINCIPAL_INVESTIGATOR
References: