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.
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.
Age < 1 year.
Pregnancy or breastfeeding.
Tattoos in the examination area.
Subcutaneous fat tissue thickness > 3 cm.
Parallel
MSOT with ICG
Diagnostic testApplication of Multispectral Optoacoustic Tomography (MSOT) in combination with the oral contrast agent Indocyanine Green (ICG) to measure gastrointestinal transit time
MRI
Diagnostic testNon-invasive MRI imaging technique will be employed to assess the peristalsis of intestinal segments
ICG signal intensitiy
Measurement of qualitative and quantitative ICG signal within the lumen of the GI tract, expressed in arbitrary units (AU).
MRI-Based Diagnostic Image Quality
Assessment of overall MRI image quality using a standardized grading scale.
MRI Motion Robustness
Evaluation of motion artifacts in MRI imaging, scored on a predefined motion robustness scale.
MRI-Based Peristalsis Frequency
Measurement of peristaltic contractions per minute in different intestinal segments.
Single-Wavelength Optoacoustic Signal
Quantitative assessment of single-wavelength optoacoustic measurements, expressed in arbitrary units (AU).
Optoacoustic Spectrum Analysis
Comprehensive optoacoustic signal analysis across multiple wavelengths, normalized in arbitrary units (AU).
Ultrasound imaging
Ultrasound imaging with assement of the presence of stool.
Gastrointestinal Symptom Assessment
Evaluation of symptom severity, including abdominal pain, nausea, diarrhea, and other gastrointestinal complaints, recorded on a standardized symptom severity scale.
Blood Test Results and Medical Findings
Analysis of laboratory test results and clinical findings extracted from medical records.
Pediatric Surgery Database Analysis
Processing and evaluation of patient data from the specialized outpatient clinic for chronic defecation disorders.
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Dr. med. Sonja Diez
Lead sponsor
Friedrich-Alexander-Universität Erlangen-Nürnberg
Sponsor institution
