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

Gastrointestinal Motility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05933096
• Other study ID #: 23-247-Bm
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: December 24, 2024

Study information

• Verified date: November 2023
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Emmanuel Nedoschill, MD
• Phone: +49 9131 85 41151
• Email: emmanuel.nedoschill[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 24, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Motility

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Erlangen	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transit-times of different segments of the gastrointestinal tract	Transit-times of the gastrointestinal passage	2 days
Secondary	Signal-intensity of ICG	Measured with MSOT in arbitrary units	2 days