Imaging the gastrointestinal tract using a new non-invasive method
Contrast-enhanced Multispectral Optoacoustic Tomography for Functional Assessment of the Gastrointestinal Transit
This study is testing a new way to see how food moves through the stomach and intestines in healthy people by using a special dye and different types of meals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Erlangen, Bavaria) |
| Trial ID | NCT05933096 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a novel imaging technique called contrast-enhanced multispectral optoacoustic tomography (MSOT) to assess gastrointestinal transit in healthy individuals. Participants will consume standardized meals mixed with Indocyanine green dye, allowing researchers to visualize and measure the dye's signal as it moves through the gastrointestinal tract. The study aims to compare the transit times of different meal consistencies—liquid, mushy, and solid—using this radiation-free and non-invasive approach.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults over the age of 18 who can provide written informed consent.
Not a fit: Patients with chronic or acute gastrointestinal diseases or those with known hypersensitivity to the dye used may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a safer and more effective way to assess gastrointestinal motility in patients.
How similar studies have performed: While this approach is innovative, similar imaging techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Erlangen, Bavaria
- University Hospital Erlangen — Erlangen, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Ferdinand Knieling, MD — Kinder- und Jugendklinik Universitätsklinikum Erlangen
- Study coordinator: Emmanuel Nedoschill, MD
- Email: emmanuel.nedoschill@uk-erlangen.de
- Phone: +49 9131 85 41151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.