Monitoring of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography
- Conditions
- Inflammatory Bowel DiseasesUlcerative ColitisCrohn Disease
- Interventions
- Diagnostic Test: Multispectral Optoacoustic Tomography
- Registration Number
- NCT06107179
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- Pregnancy
- Nursing mothers
- Cardiopulmonary unstable patients*: Need for continuous cardiopulmonary monitoring
- Tattoo in the area of the examination field
- Subcutaneous fat > 3 cm
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Crohns Disease Multispectral Optoacoustic Tomography Patients with Crohns Disease Ulcerative Colitis Multispectral Optoacoustic Tomography Patients with Ulcerative Colitis
- Primary Outcome Measures
Name Time Method MSOT signal for hemoglobin in the intestinal wall of participants 6 - 12 months Longitudinal analysis of MSOT signal for oxygenated and deoxygenated hemoglobin in the intestinal wall of children and adolescents with CD and UC.
- Secondary Outcome Measures
Name Time Method Laboratory parameters (blood - c-reactive protein (CrP)) (if applicable) 6 - 12 months Assessment of disease status by laboratory parameters (CrP) within different entities of IBD (CD vs. UC)
Endoscopic extent of inflammation (if applicable) 6 - 12 months Assessment of inflammation in endoscopies 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)
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)
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 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 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)
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.)
Ultrasound 6 - 12 months Assessment of disease status by ultrasound within different entities of IBD (CD vs. 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.)
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)
MRI (if applicable) 6 - 12 months Assessment of disease status by MRI within different entities of IBD (CD vs. UC)
Trial Locations
- Locations (1)
University Hospital Erlangen
🇩🇪Erlangen, Bavaria, Germany