NCT06911749

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Apr 2025Jun 2026

First Submitted

Initial submission to the registry

February 25, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

September 3, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

February 25, 2025

Last Update Submit

August 31, 2025

Conditions

Chronic ConstipationSlow Transit ConstipationIntestinal Transit DisorderHirschsprungs Disease

Keywords

slow transit constipationMSOTICGgastrointestinal transitHirschsprungs Disease

Outcome Measures

Primary Outcomes (5)

  • ICG signal intensitiy

    Measurement of qualitative and quantitative ICG signal within the lumen of the GI tract, expressed in arbitrary units (AU).

    From enrollment to the end of measurements after one week

  • MRI-Based Diagnostic Image Quality

    Assessment of overall MRI image quality using a standardized grading scale.

    From enrollment to the end of measurements after one week

  • MRI Motion Robustness

    Evaluation of motion artifacts in MRI imaging, scored on a predefined motion robustness scale.

    Time Frame: From enrollment to the end of measurements after one week.

  • MRI-Based Peristalsis Frequency

    Measurement of peristaltic contractions per minute in different intestinal segments.

    Time Frame: From enrollment to the end of measurements after one week

  • MRI-Based Peristalsis Amplitude

    Quantification of bowel wall movement amplitude in millimeters (mm).

    Time Frame: From enrollment to the end of measurements after one week.

Secondary Outcomes (5)

  • Single-Wavelength Optoacoustic Signal

    From enrollment to the end of measurements after one week

  • Optoacoustic Spectrum Analysis

    From enrollment to the end of measurements after one week

  • Ultrasound imaging

    From enrollment to the end of measurements after one week

  • Gastrointestinal Symptom Assessment

    From enrollment to the end of the study after one year.

  • Demographic parameters

    From enrollment to the end of measurements after one week

Other Outcomes (2)

  • Blood Test Results and Medical Findings

    From enrollment to the end of the study after one year

  • Pediatric Surgery Database Analysis

    From enrollment to the end of the study after one year.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Diagnostic Test: MSOT with ICGDiagnostic Test: MRI

Transit Disorder Group

ACTIVE COMPARATOR

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.

Diagnostic Test: MSOT with ICGDiagnostic Test: MRI

Interventions

MSOT with ICGDIAGNOSTIC_TEST

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

Control GroupTransit Disorder Group
MRIDIAGNOSTIC_TEST

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

Control GroupTransit Disorder Group

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Erlangen, Pediatric Surgery

Erlangen, Bavaria, 91054, Germany

RECRUITING

Related Publications (1)

  • Paulus LP, Buehler A, Wagner AL, Raming R, Jungert J, Simon D, Tascilar K, Schnell A, Rother U, Eckstein M, Lang W, Hoerning A, Schett G, Neurath MF, Waldner MJ, Trollmann R, Woelfle J, Bohndiek SE, Regensburger AP, Knieling F. Contrast-Enhanced Multispectral Optoacoustic Tomography for Functional Assessment of the Gastrointestinal Tract. Adv Sci (Weinh). 2023 Aug;10(23):e2302562. doi: 10.1002/advs.202302562. Epub 2023 Jun 8.

    PMID: 37289088BACKGROUND

MeSH Terms

Conditions

Hirschsprung Disease

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesMegacolonColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Sonja Diez, PD Dr. med.

    Friedrich-Alexander-Universität Erlangen-Nürnberg

    PRINCIPAL INVESTIGATOR

  • Adrian Regensburger, PD Dr. med.

    Friedrich-Alexander-Universität Erlangen-Nürnberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederike Bieling

CONTACT

+49 9131 85 32923frederike.bieling@uk-erlangen.de

Sonja Diez, PD Dr. med.

CONTACT

+49 9131 85 32923sonja.diez@uk-erlangen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: This study is a monocentric observational study with prospective data collection. It is conducted as an Investigator-Initiated Trial (IIT).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PD Dr. med. Sonja Diez

Study Record Dates

First Submitted

February 25, 2025

First Posted

April 4, 2025

Study Start

April 15, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

September 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)