Contrast-Enhanced Multispectral Optoacoustic Tomography for Functional Assessment of the Gastrointestinal Tract.
Lars-Philip Paulus, Adrian Buehler, Alexandra L Wagner...
https://pubmed.ncbi.nlm.nih.gov/37289088Actively Recruiting
Phase Not Applicable
Age: 1Year +
All Genders
Healthy Volunteers
ID06911749
Contrast Enhanced Multispectral Optoacoustic Tomography and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders
Led by Dr. med. Sonja Diez · Updated on 2025-09-03
20
Participants Needed
1
Research Sites
21 weeks
Total Duration
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AI-Summary
What this Trial Is About
This research aims to improve the diagnosis of chronic bowel emptying disorders in children aged 0 to 17 years. It focuses on evaluating a new, non-invasive method combining Multispectral Optoacoustic Tomography (MSOT) with the oral contrast agent Indocyanine Green (ICG) and a radiation-free MRI technique to measure gastrointestinal transit time and assess intestinal peristalsis. The study addresses challenges in differentiating between slow transit constipation and outlet obstruction, conditions that affect bowel movement in children and often require targeted therapy. Participants are divided into two groups: a control group of healthy adults and an intervention group of children with chronic defecation disorders such as idiopathic chronic constipation, slow transit constipation, or outlet obstruction. Both groups undergo MSOT combined with oral ICG to track gastrointestinal transit and MRI scans to observe bowel movement patterns. The study collects and standardizes data from these imaging methods over a one-week measurement period. During the study, participants will have their gastrointestinal transit time and peristalsis evaluated through imaging and clinical assessments. Researchers will monitor ICG signal intensity and MRI image quality, motion robustness, peristalsis frequency, and amplitude. Additional assessments include ultrasound imaging and symptom questionnaires extending up to one year. The project aims to optimize therapy by identifying intestinal segments with delayed transit and improving diagnostic accuracy without using radiation or invasive procedures.
CONDITIONS
Brief Title
MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders
Who Can Participate
Age: 1Year +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Written informed consent from the participant (from age 6) and legal guardian(s) for patients
- Suspected or confirmed chronic defecation disorder diagnosis
- Age up to 18 years for patients
- Sufficient German language skills to understand study documents
- Written informed consent for healthy adult controls
- Age over 18 years for healthy adult controls
- BMI under 25 or medically suitable for MSOT examination as assessed by a physician
- Willingness and ability to participate
You will not qualify if you...
- Age under 1 year
- Pregnancy or breastfeeding
- Tattoos in the examination area
- Subcutaneous fat tissue thickness over 3 cm
- Known allergy to Indocyanine Green, sodium iodide, or iodine
- Thyroid dysfunction including hyperthyroidism or thyroid autonomy
- Recent radioactive iodine treatment within two weeks before or after study
- Impaired kidney 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, or any injection containing sodium bisulfite
- Contraindications for MRI such as electrical implants (pacemakers, pumps)
- Severe claustrophobia preventing MRI examination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 week
Participants undergo non-invasive diagnostic testing including Multispectral Optoacoustic Tomography (MSOT) with oral Indocyanine Green (ICG) and MRI imaging to assess gastrointestinal transit time and peristalsis.
Multiple visits within one week for MSOT and MRI assessments
Long-term Monitoring
Duration - Up to 1 year
Participants are monitored for gastrointestinal symptoms and other outcomes up to one year after the diagnostic assessments.
Periodic follow-up visits or contacts over one year
Trial Site Locations
Total: 1 location
1
University Hospital Erlangen, Pediatric Surgery
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
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Research Team
F
Frederike Bieling
S
Sonja Diez, PD Dr. med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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