Radiation-free imaging to measure intestinal transit time in children
Contrast Enhanced Multispectral Optoacoustic Tomography and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders
This project will try a radiation-free imaging method (MSOT) with an oral dye plus MRI to measure how quickly stool moves through the intestines in children and teenagers with chronic bowel emptying disorders.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Friedrich-Alexander-Universität Erlangen-Nürnberg Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Erlangen, Bavaria) |
| Trial ID | NCT06911749 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children and adolescents up to 17 years with suspected or confirmed chronic bowel emptying disorders whose guardians can provide written consent and who can attend the University Hospital Erlangen are the intended participants.
Not a fit: Patients with known hypersensitivity to ICG or iodine, significant subcutaneous fat thickness over the scan area (>3 cm), tattoos at the examination site, thyroid dysfunction, infants under 1 year, or those unable to travel to Erlangen are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could offer a non-invasive, radiation-free way to measure intestinal transit and help guide treatment choices for children with chronic constipation and related disorders.
How similar studies have performed: Using MSOT with oral ICG for gastrointestinal transit in children is experimental with limited prior clinical data, while contrast-free MRI for intestinal motility has been used in research settings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Erlangen, Bavaria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.