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

Launched by DR. MED. SONJA DIEZ · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to measure how food and waste move through the intestines in children aged 0 to 17 who have problems with bowel movements, such as chronic constipation or disorders like Hirschsprung's disease. The researchers at the University Hospital Erlangen are using a special imaging technique called Multispectral Optoacoustic Tomography (MSOT) combined with a safe oral contrast agent called Indocyanine Green (ICG). This method is radiation-free and helps doctors see how well the intestines are working without needing invasive procedures.

To participate, children must have a suspected or confirmed bowel movement disorder and be willing to join the study with consent from their parents or guardians. Healthy adults over 18 may also join as a control group. Participants will undergo non-invasive tests to measure how quickly food moves through their intestines and to check the function of different intestinal segments. This study aims to improve treatment options for children with these conditions by providing more accurate information about their digestive health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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,
• • Any injection containing sodium bisulfite.
• • General contraindications for MRI, such as electrical implants (e.g., pacemakers, perfusion pumps).
• • Severe claustrophobia preventing MRI examination.