Actively Recruiting
MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders
Led by Dr. med. Sonja Diez · Updated on 2025-09-03
20
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The project presented here is a monocentric clinical study conducted by the Pediatric Surgery and Pediatrics departments of the University Hospital Erlangen. The study aims to experimentally expand the diagnostic approach for patients aged 0-17 years suffering from chronic bowel emptying disorders, regardless of any underlying causal or previously treated conditions. At the core of this clinical study is the application of Multispectral Optoacoustic Tomography (MSOT) in combination with the oral contrast agent Indocyanine Green (ICG) to measure gastrointestinal transit time in children. Unlike conventional X-ray diagnostics, MSOT is radiation-free and considered non-invasive, although it has not yet been standardized for routine clinical use. Additionally, a contrast-free, non-invasive MRI technique will be employed to assess the peristalsis of intestinal segments. The study aims to standardize the collection and evaluation of patient data following the administration of ICG and subsequent measurements using MSOT and MRI. The objective is to assess gastrointestinal transit time and peristalsis and, ultimately, to optimize therapy for affected patients. This is of particular importance in the coloproctology specialist consultation within the Pediatric Surgery and Pediatrics departments, as follows: It enables differentiation between patients with slow transit constipation and outlet obstruction. It allows for a more targeted application and evaluation of neuromodulation therapy, which is used within clinical studies. This approach allows for the identification of specific intestinal segments with delayed transit time, enabling targeted electrical stimulation of these regions. A control group of healthy adult volunteers will participate in the study on a voluntary basis.
CONDITIONS
Official Title
MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent from the participant (starting at age 6) and legal guardian(s)
- Suspected or confirmed diagnosis of chronic defecation disorder
- Age 18 years or younger
- Willingness and ability to participate
- Sufficient German language skills to understand the informed consent document
- For control group: written informed consent, age over 18 years, BMI under 25 or medically suitable for MSOT examination
You will not qualify if you...
- Age under 1 year
- Pregnancy or breastfeeding
- Tattoos in the examination area
- Subcutaneous fat tissue thicker than 3 cm
- Known allergy to Indocyanine Green (ICG), sodium iodide, or iodine
- Thyroid problems such as hyperthyroidism or thyroid autonomy
- Recent radioactive iodine treatment within two weeks before or after the study
- Impaired kidney function
- Use of certain medications including beta-blockers, anticonvulsants, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin, or any injections containing sodium bisulfite
- Contraindications for MRI such as electrical implants like pacemakers or perfusion pumps
- Severe claustrophobia preventing MRI examination
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Erlangen, Pediatric Surgery
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
Research Team
F
Frederike Bieling
CONTACT
S
Sonja Diez, PD Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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