CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Multispectral optoacoustic tomography (MSOT)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05160077
NCT05160077N/ACompleted

Noninvasive Characterization of Postprandial Intestinal Blood Flow Using Multispectral Optoacoustic Tomography

University of Erlangen-Nürnberg Medical School·interventional·Posted Dec 16, 2021·Updated Jul 19, 2022

In Brief

A clinical study evaluating Multispectral optoacoustic tomography (MSOT) for Digestive System Disease and Inflammatory Bowel Diseases. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Inflammatory activities in the gastrointestinal tract are accompanied by an increase in blood flow in the intestinal wall layers of the respective organs. Also in chronic inflammatory bowel diseases, the release of vasoactive inflammatory mediators leads to vasodilation and consecutive increase of blood flow in the bowel wall. So far, these changes in blood flow can be detected by power Doppler sonography without being part of routine clinical diagnostics. Another promising option for non-invasive measurement of blood flow in the intestinal wall is Multispectral Optoacoustic Tomography (MSOT). Previous studies have shown that MSOT can be used to quantitatively measure hemoglobin in the bowel wall and thus provide information on blood flow and inflammatory activity in the intestines of patients with Crohn's disease. This is currently being further investigated in a pivotal study (Euphoria, H2020) and could lead to the possibility of non-invasive assessment of disease activity in inflammatory bowel disease (IBD) in the future. The regional blood flow in the intestinal wall and the distribution of gastrointestinal blood flow are also subject to strong postprandial changes. During absorption of food components, blood flow increases sequentially in the respective sections of the gastrointestinal tract, leading to postprandial hyperemia. Because postprandial hyperemia is particularly regulated locally by the presence of dietary components, there is a relationship between the sequential increase in blood flow in the intestinal wall and the peristaltic transport of chyme through the gastrointestinal tract. Postprandial hyperemia could also lead to an increase in the optoacoustic hemoglobin signal of the intestinal wall and thus have an impact on the assessment of inflammatory activity in IBD using MSOT. Additionally, MSOT allows the identification of non-absorbable exogenous chromophores, such as indocyanine green (ICG), which could allow co-localization of the chyme in the intestinal lumen after oral application of ICG. This pilot study investigates whether postprandial blood flow changes can be quantitatively measured using MSOT and whether these changes occur simultaneously with the gastrointestinal passage of the chyme as measured by the ICG signal in the intestinal lumen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 16, 2021
Enrollment StartNov 23, 2021
Primary CompletionJan 15, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.5 years ago

Interventions

Multispectral optoacoustic tomography (MSOT)other

MSOT Acuity Echo, iThera medical, Munich