Contrast-enhanced Multispectral Optoacoustic Tomography f... | NCT05933096

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

NCT05933096

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Unknown status

Last Update Posted

Nov 21, 2023Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Gastrointestinal Motility

Interventions

Contrast-enhanced multispectral optoacoustic tomography

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 17, 2023Actual

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Dec 24, 2024Estimated

First Submitted Date

Jun 27, 2023

First Submission Date that Met QC Criteria

Jun 27, 2023

First Posted Date

Jul 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2023

Last Update Posted Date

Nov 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ferdinand Knieling, Dr. med. habil Ferdinand Knieling, University of Erlangen-Nürnberg Medical SchoolPrincipal Investigator

Lead Sponsor

University of Erlangen-Nürnberg Medical SchoolOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emmanuel Nedoschill, MD	Contact	+49 9131 85 41151		emmanuel.nedoschill@uk-erlangen.de

Overall Officials

Name	Affiliation	Role
Ferdinand Knieling, MD	Kinder- und Jugendklinik Universitätsklinikum Erlangen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Erlangen	Recruiting	Erlangen	Bavaria	91054	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided