Gastrointestinal MotilityNCT05933096
Contrast-enhanced Multispectral Optoacoustic Tomography for Functional Assessment of the Gastrointestinal Transit
A study testing Contrast-enhanced multispectral optoacoustic tomography in people with Gastrointestinal Motility, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Motility
- What is being tested?
- Contrast-enhanced multispectral optoacoustic tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 17 Nov 2023to 24 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Written informed consent
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Erlangen
Erlangen, Bavaria, 91054
Emmanuel Nedoschill, 091318541151, emmanuel.nedoschill@uk-erlangen.de
About this study
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.
Read the 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.
- Conditions
- Gastrointestinal Motility
- Being tested
- Contrast-enhanced multispectral optoacoustic tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced multispectral optoacoustic tomographyDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Breakfast 1 | Experimental | Breakfast 1 is composed of 500 ml of water, mixed with 50 mg of ICG Receives: Diagnostic Test: Contrast-enhanced multispectral optoacoustic tomography |
| Breakfast 2 | Experimental | Breakfast 2 is composed of 200ml of yoghurt, mixed with 50 mg of ICG Receives: 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 Receives: Diagnostic Test: Contrast-enhanced multispectral optoacoustic tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transit-times of different segments of the gastrointestinal tract
Transit-times of the gastrointestinal passage
Measured: 2 days
Secondary outcomes (1)
Signal-intensity of ICG
Measured with MSOT in arbitrary units
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start17 Nov 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion24 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal MotilityStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferdinand Knieling, University of Erlangen-Nürnberg Medical School
- Investigators
- Ferdinand Knieling, MD, Principal investigator, Kinder- und Jugendklinik Universitätsklinikum Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933096
- Sponsor's protocol ID
- 23-247-Bm
- Status last verified
- Nov 2023
- First submitted
- 27 Jun 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced Multispectral Optoacoustic Tomography for Functional Assessment of the Gastrointestinal Transit
- ClinicalTrials.gov ID
- NCT05933096
- Acronym / sponsor ID
- 23-247-Bm
- Conditions
- Gastrointestinal Motility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 24 Dec 2024 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Breakfast 1 | Experimental | Diagnostic Test: Contrast-enhanced multispectral optoacoustic tomographyBreakfast 1 is composed of 500 ml of water, mixed with 50 mg of ICG |
| Breakfast 2 | Experimental | Diagnostic Test: Contrast-enhanced multispectral optoacoustic tomographyBreakfast 2 is composed of 200ml of yoghurt, mixed with 50 mg of ICG |
| Breakfast 3 | Experimental | Diagnostic Test: Contrast-enhanced multispectral optoacoustic tomographyBreakfast 3 is composed of two slices white toast, two fried eggs and 30 g of jam, mixed with 50 mg of ICG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 18 years
- Written informed consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-enhanced multispectral optoacoustic tomographyIngestion 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 | Diagnostic test | Breakfast 1, Breakfast 2, Breakfast 3 |
Primary outcome
Transit-times of different segments of the gastrointestinal tract
Time frame: 2 days
Transit-times of the gastrointestinal passage
1 secondary outcome
Signal-intensity of ICG
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferdinand Knieling, MD principal investigator
Kinder- und Jugendklinik Universitätsklinikum Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-enhanced multispectral optoacoustic tomography in people with Gastrointestinal Motility, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel Nedoschill, MD (+49 9131 85 41151, emmanuel.nedoschill@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transit-times of different segments of the gastrointestinal tract (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.