Contrast Enhanced Multispectral Optoacoustic Tomography and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: t
View:

⁃ 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.

Locations
Other Locations
Germany
University Hospital Erlangen, Pediatric Surgery
RECRUITING
Erlangen
Contact Information
Primary
Frederike Bieling
frederike.bieling@uk-erlangen.de
+49 9131 85 32923
Backup
Sonja Diez, PD Dr. med.
sonja.diez@uk-erlangen.de
+49 9131 85 32923
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 20
Treatments
Active_comparator: Control Group
The control group consists of young, healthy adults without bowel emptying disorders. The aim of this group is to provide baseline measurements for gastrointestinal transit time and peristalsis using Multispectral Optoacoustic Tomography (MSOT) and MRI, allowing for comparison with the intervention group and ensuring the reliability of the diagnostic approach.
Active_comparator: Transit Disorder Group
The intervention group consists of pediatric patients suffering from chronic defecation disorders, including idiopathic chronic constipation, slow transit constipation (STC), and outlet obstruction (OO). The aim of the intervention is to assess gastrointestinal transit time and peristalsis using a novel, non-invasive combination of Multispectral Optoacoustic Tomography (MSOT) and MRI.
Related Therapeutic Areas
Sponsors
Leads: Dr. med. Sonja Diez

This content was sourced from clinicaltrials.gov