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

Sponsor
University of Erlangen-Nürnberg Medical School (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05933096
Collaborator
(none)
10
Enrollment
3
Arms
5.3
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Contrast-enhanced multispectral optoacoustic tomography
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Contrast-enhanced Multispectral Optoacoustic Tomography for Functional Assessment of the Gastrointestinal Transit
Anticipated Study Start Date :
Jul 15, 2023
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 24, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Transit-times of different segments of the gastrointestinal tract [2 days]

    Transit-times of the gastrointestinal passage

Secondary Outcome Measures

  1. Signal-intensity of ICG [2 days]

    Measured with MSOT in arbitrary units

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Erlangen-Nürnberg Medical School

Investigators

  • Principal Investigator: Ferdinand Knieling, MD, Kinder- und Jugendklinik Universitätsklinikum Erlangen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ferdinand Knieling, Dr. med. habil Ferdinand Knieling, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT05933096
Other Study ID Numbers:
  • 23-247-Bm
First Posted:
Jul 6, 2023
Last Update Posted:
Jul 6, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 6, 2023