Radiation-free imaging to measure intestinal transit time in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This monocentric project at University Hospital Erlangen uses Multispectral Optoacoustic Tomography (MSOT) together with orally administered Indocyanine Green (ICG) to track gastrointestinal transit time in pediatric patients. A contrast-free MRI technique will also be used to visualize peristalsis of intestinal segments without radiation. The protocol aims to standardize how images and clinical data are collected after ICG administration and to compare MSOT findings with MRI and clinical presentation. The approach targets children and adolescents up to 17 years old with suspected or confirmed chronic defecation disorders of various causes.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital Erlangen, Pediatric Surgery
  Erlangen, Bavaria, Germany Recruiting

Study contacts

• Principal investigator: Sonja Diez, PD Dr. med. — Friedrich-Alexander-Universität Erlangen-Nürnberg
• Study coordinator: Frederike Bieling
• Email: frederike.bieling@uk-erlangen.de
• Phone: +49 9131 85 32923

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.