MSOT with ICG: Application of Multispectral Optoacoustic Tomography (MSOT) in combination with the oral contrast agent Indocyanine Green (ICG) to measure gastrointestinal transit time
MRI: Non-invasive MRI imaging technique will be employed to assess the peristalsis of intestinal segments
Study 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
Sex
ALL
Min age
1 Year
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
ICG signal intensitiy — From enrollment to the end of measurements after one week Measurement of qualitative and quantitative ICG signal within the lumen of the GI tract, expressed in arbitrary units (AU).
MRI-Based Diagnostic Image Quality — From enrollment to the end of measurements after one week Assessment of overall MRI image quality using a standardized grading scale.
MRI Motion Robustness — Time Frame: From enrollment to the end of measurements after one week. Evaluation of motion artifacts in MRI imaging, scored on a predefined motion robustness scale.
MRI-Based Peristalsis Frequency — Time Frame: From enrollment to the end of measurements after one week Measurement of peristaltic contractions per minute in different intestinal segments.
MRI-Based Peristalsis Amplitude — Time Frame: From enrollment to the end of measurements after one week. Quantification of bowel wall movement amplitude in millimeters (mm).
Trial sites (1)
Facility
City
Region
Status
University Hospital Erlangen, Pediatric Surgery
Erlangen
Bavaria
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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