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

NCT05933096 | Unknown

• 1 other identifier: 23-247-Bm
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Motility

Outcome Measures

Primary Outcomes (1)

• Transit-times of different segments of the gastrointestinal tract

  Transit-times of the gastrointestinal passage

  2 days

Secondary Outcomes (1)

• Signal-intensity of ICG

  2 days

Study Arms (3)

Breakfast 1

EXPERIMENTAL

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

Diagnostic Test: Contrast-enhanced multispectral optoacoustic tomography

Breakfast 2

EXPERIMENTAL

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

Diagnostic Test: Contrast-enhanced multispectral optoacoustic tomography

Breakfast 3

EXPERIMENTAL

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

Interventions

Contrast-enhanced multispectral optoacoustic tomography 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 1; Breakfast 2; Breakfast 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

Study Officials

• Ferdinand Knieling, MD

  Kinder- und Jugendklinik Universitätsklinikum Erlangen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel Nedoschill, MD

CONTACT

+49 9131 85 41151; emmanuel.nedoschill@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. habil Ferdinand Knieling

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 6, 2023
• Study Start: November 17, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 24, 2024
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

DE (1)