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

NCT ID: NCT05933096

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-17

Study Completion Date

2024-12-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastrointestinal Motility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Subjects will ingest three different standardized meals called breakfast 1, breakfast 2, and breakfast 3. They will ingest one meal per day, there is a minimum of 48 hours between measurement days. Every subject will ingest every meal.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Breakfast 1

Breakfast 1 is composed of 500 ml of water, mixed with 50 mg of ICG

Group Type EXPERIMENTAL

Contrast-enhanced multispectral optoacoustic tomography

Intervention Type DIAGNOSTIC_TEST

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

Breakfast 2

Breakfast 2 is composed of 200ml of yoghurt, mixed with 50 mg of ICG

Group Type EXPERIMENTAL

Contrast-enhanced multispectral optoacoustic tomography

Intervention Type DIAGNOSTIC_TEST

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

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

Group Type EXPERIMENTAL

Contrast-enhanced multispectral optoacoustic tomography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Ferdinand Knieling

Dr. med. habil Ferdinand Knieling

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ferdinand Knieling, MD

Role: PRINCIPAL_INVESTIGATOR

Kinder- und Jugendklinik Universitätsklinikum Erlangen

Locations

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University Hospital Erlangen

Erlangen, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Emmanuel Nedoschill, MD

Role: CONTACT

[email protected]
+49 9131 85 41151

Facility Contacts

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Emmanuel Nedoschill

Role: primary

[email protected]
091318541151

Other Identifiers

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23-247-Bm

Identifier Type: -

Identifier Source: org_study_id