MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders

Recruiting now · Not applicable

Conditions studied: Chronic Constipation, Slow Transit Constipation, Intestinal Transit Disorder, Hirschsprungs Disease

In brief

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.

Key facts

Study ID

NCT06911749

Run by

Dr. med. Sonja Diez

People needed

20

Starts

2025-04-15

Expected to finish

2026-06-01

Last updated by the study team

2025-09-03

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient Group
• Written informed consent from the participant (starting at age 6).
• Written informed consent from the legal guardian(s).
• Suspected or confirmed diagnosis of chronic defecation disorder.
• Age ≤ 18 years.
• Willingness and ability to participate, with sufficient German language skills to understand the informed consent document.
• Control Group
• Written informed consent from the participant.
• Age > 18 years.
• BMI < 25 or medical suitability for MSOT examination as assessed by a physician.
• Willingness and ability to participate, with sufficient German language skills to understand the informed consent document.

You may not qualify if…

• Age < 1 year.
• Pregnancy or breastfeeding.
• Tattoos in the examination area.
• Subcutaneous fat tissue thickness > 3 cm.
• Known hypersensitivity to ICG, sodium iodide, or iodine.
• Thyroid dysfunction, including hyperthyroidism or focal/diffuse thyroid autonomy.
• Recent thyroid function testing with radioactive iodine treatment (within two weeks before or after the study).
• Impaired renal function.
• Use of specific medications, including:
• Beta-blockers,
• Anticonvulsants,
• Cyclopropane,
• Bisulfite compounds,
• Haloperidol,
• Heroin,
• Meperidine,
• Metamizole,
• Methadone,
• Morphine,
• Nitrofurantoin,
• Opium alkaloids,
• Phenobarbital,
• Phenylbutazone,
• Probenecid,
• Rifamycin,

Where it is running

• University Hospital Erlangen, Pediatric Surgery — Erlangen, Bavaria, Germany (enrolling)

Full record on ClinicalTrials.gov

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