RecruitingNot ApplicableNCT06911749

MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders

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


Sponsor

Dr. med. Sonja Diez

Enrollment

20 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 Year

Inclusion Criteria11

  • 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 Criteria28

  • 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.

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Interventions

DIAGNOSTIC_TESTMSOT with ICG

Application of Multispectral Optoacoustic Tomography (MSOT) in combination with the oral contrast agent Indocyanine Green (ICG) to measure gastrointestinal transit time

DIAGNOSTIC_TESTMRI

Non-invasive MRI imaging technique will be employed to assess the peristalsis of intestinal segments


Locations(1)

University Hospital Erlangen, Pediatric Surgery

Erlangen, Bavaria, Germany

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NCT06911749


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