Contrast-enhanced Multispectral Optoacoustic Tomography for Functional Assessment of the Gastrointestinal Transit

This clinical trial aims to characterize a novel method of imaging the gastrointestinal tract in healthy subjects. The method is using laser-light and soundwaves and it is performed in a similar manner as conventional ultrasound. It is radiation-free and non-invasive.

Participants will ingest food mixed with the clinically-registered dye Indocyanine green. Researchers will measure the signal of the dye over different segments of the gastrointestinal tract, visualizing gastrointestinal transit.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Motility
• Intervention / Treatment: Diagnostic test: Contrast-enhanced multispectral optoacoustic tomography

Detailed Description

This clinical trial aims to assess gastrointestinal transit by using contrast-enhanced multispectral optoacoustic tomography (MSOT). MSOT is able to visualize not only endogenous chromophores like hemoglobin but also exogenous chromophores such as Indocyanine green (ICG). Healthy subjects will ingest three different standardized meals, all of which are mixed with ICG. By measuring the signal intensity of ICG during gastrointestinal transit, gut motility can be assessed non-invasive and radiation free.

The goal is to compare transit times for different standardized meals, which are liquid, mushy, and solid.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emmanuel Nedoschill, MD; Phone Number: +49 9131 85 41151; Email: emmanuel.nedoschill@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • University Hospital Erlangen
      • Contact: Emmanuel Nedoschill; Phone Number: 091318541151; Email: emmanuel.nedoschill@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

• Age over 18 years
• Written informed consent

Exclusion Criteria:

General:

• Pregnancy
• Breastfeeding mothers
• Tattoo in the area of the examination
• Subcutaneous fat tissue over 3 cm
• Chronic or acute diseases of the gastrointestinal tract or symptoms suggesting such a disease
• Acute diseases requiring treatment
• Lack of written consent

ICG related:

• Known hypersensitivity to ICG, sodium iodide or iodine.
• Hyperthyroidism, focal or diffuse thyroid autonomy.
• Timely close treatment to check thyroid function with ingestion of radioactive iodine (within two weeks before or after the study)
• Impaired renal function
• Taking the following medications: Beta blockers, anticonvulsants, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin, any injection containing sodium bisulfite

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breakfast 1; Breakfast 1 is composed of 500 ml of water, mixed with 50 mg of ICG	Diagnostic test: Contrast-enhanced multispectral optoacoustic tomography; Ingestion of ICG-labeled food and 10 measurements with MSOT, 1 before ingestion of food, 8 afterwards, each after 60 minutes, 1 measurement 24 hours after ingestion
Experimental: Breakfast 2; Breakfast 2 is composed of 200ml of yoghurt, mixed with 50 mg of ICG	Diagnostic test: Contrast-enhanced multispectral optoacoustic tomography; Ingestion of ICG-labeled food and 10 measurements with MSOT, 1 before ingestion of food, 8 afterwards, each after 60 minutes, 1 measurement 24 hours after ingestion
Experimental: Breakfast 3; Breakfast 3 is composed of two slices white toast, two fried eggs and 30 g of jam, mixed with 50 mg of ICG	Diagnostic test: Contrast-enhanced multispectral optoacoustic tomography; Ingestion of ICG-labeled food and 10 measurements with MSOT, 1 before ingestion of food, 8 afterwards, each after 60 minutes, 1 measurement 24 hours after ingestion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transit-times of different segments of the gastrointestinal tract	Transit-times of the gastrointestinal passage	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signal-intensity of ICG	Measured with MSOT in arbitrary units	2 days

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: Ferdinand Knieling, MD, Kinder- und Jugendklinik Universitätsklinikum Erlangen

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 24, 2024

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 23-247-Bm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No