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

RecruitingNAAges 1 Year - anyAllDr. med. Sonja Diez
NCT06911749 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 st

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📋 Eligibility rules (as published)
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.
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What it tests

  • MSOT with ICG
  • MRI
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Where

1 site
University Hospital Erlangen, Pediatric Surgery
Erlangen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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