Optoacoustic Characterization of Postprandial Intestinal Blood Flow

NCT05160077 | Completed

• 1 other identifier: 346_21 B
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Digestive System Disease; Inflammatory Bowel Diseases

Keywords

optoacoustic; photoacoustic; MSOT; IBD

Outcome Measures

Primary Outcomes (1)

• Change of the quantitative de-/oxygenated hemoglobin signal (in arbitrary units)

  Change of the quantitative de-/oxygenated hemoglobin signal in the wall of the gastrointestinal tract (gastric antrum, terminal ileum, transverse colon, and sigmoid colon) over a postprandial time of 7 hours.

  every 60 minutes over 8 hours on each of the three examination days

Secondary Outcomes (8)

• Change of the qualitative and quantitative ICG signal (in arbitrary units)

  every 60 minutes over 8 hours on on the third examination day

• Change of the quantitative single wavelengths signal (in arbitrary units)

  every 60 minutes over 8 hours on each of the three examination days

• Change of the optoacoustic spectrum (in arbitrary units, normalized)

  every 60 minutes over 8 hours on each of the three examination days

• Change of Blood flow in the big splanchnic arteries.

  every 60 minutes over 8 hours on each of the three examination days

• Change of Resistance Index in the big splanchnic arteries.

  every 60 minutes over 8 hours on each of the three examination days

Study Arms (3)

Fasting

OTHER

All examinations are in a fasting state.

Diagnostic Test: Multispectral optoacoustic tomography (MSOT)

Standardised Breakfast

OTHER

Preprandial examination is in fasting state, all postprandial examinations will be conducted with standardized dietary. 30 minutes after the beginning of the preprandial examination participants receive an standardized breakfast. 270 minutes after the beginning of the preprandial examination participants receive an standardised meal.

Diagnostic Test: Multispectral optoacoustic tomography (MSOT)

Standardised Breakfast and ICG

OTHER

Preprandial examination are in a fasting state, all postprandial examinations will be conducted with standardized dietary including indocyanine green (ICG) dye. 30 minutes after the beginning of the preprandial examination participants receive an standardised breakfast containing ICG. 270 minutes after the beginning of the preprandial examination participants receive an standardised meal without ICG.

Diagnostic Test: Multispectral optoacoustic tomography (MSOT)

Interventions

Multispectral optoacoustic tomography (MSOT) DIAGNOSTIC_TEST

MSOT Acuity Echo, iThera medical, Munich

Fasting; Standardised Breakfast; Standardised Breakfast and ICG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Written declaration of consent

You may not qualify if:

• Generally valid:
• Pregnancy
• Nursing mothers
• Tattoo in the field of investigation
• Subcutaneous fat tissue over 3 cm
• Chronic or acute diseases of the gastrointestinal tract or symptoms suggestive of such a disease
• Diseases requiring acute treatment
• Lack of written consent
• ICG related:
• Known hypersensitivity to ICG, sodium iodide or iodine
• Hyperthyroidism, focal or diffuse thyroid autonomy
• Treatment with radioactive iodine for the diagnostic examination of thyroid function within two weeks before or after the study
• Restricted renal function
• Intake of the following drugs: Beta-blockers, anticonvulsants, cyclopropane, bisulphite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin, any injection containing sodium bisulphite.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (13)

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  PMID: 10945962 BACKGROUND

• Deban L, Correale C, Vetrano S, Malesci A, Danese S. Multiple pathogenic roles of microvasculature in inflammatory bowel disease: a Jack of all trades. Am J Pathol. 2008 Jun;172(6):1457-66. doi: 10.2353/ajpath.2008.070593. Epub 2008 May 5.

  PMID: 18458096 BACKGROUND

• Calabrese E, Maaser C, Zorzi F, Kannengiesser K, Hanauer SB, Bruining DH, Iacucci M, Maconi G, Novak KL, Panaccione R, Strobel D, Wilson SR, Watanabe M, Pallone F, Ghosh S. Bowel Ultrasonography in the Management of Crohn's Disease. A Review with Recommendations of an International Panel of Experts. Inflamm Bowel Dis. 2016 May;22(5):1168-83. doi: 10.1097/MIB.0000000000000706.

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• Ntziachristos V, Razansky D. Molecular imaging by means of multispectral optoacoustic tomography (MSOT). Chem Rev. 2010 May 12;110(5):2783-94. doi: 10.1021/cr9002566. No abstract available.

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• Weber J, Beard PC, Bohndiek SE. Contrast agents for molecular photoacoustic imaging. Nat Methods. 2016 Jul 28;13(8):639-50. doi: 10.1038/nmeth.3929.

  PMID: 27467727 BACKGROUND

• Regensburger AP, Brown E, Kronke G, Waldner MJ, Knieling F. Optoacoustic Imaging in Inflammation. Biomedicines. 2021 Apr 28;9(5):483. doi: 10.3390/biomedicines9050483.

  PMID: 33924983 BACKGROUND

• Knieling F, Neufert C, Hartmann A, Claussen J, Urich A, Egger C, Vetter M, Fischer S, Pfeifer L, Hagel A, Kielisch C, Gortz RS, Wildner D, Engel M, Rother J, Uter W, Siebler J, Atreya R, Rascher W, Strobel D, Neurath MF, Waldner MJ. Multispectral Optoacoustic Tomography for Assessment of Crohn's Disease Activity. N Engl J Med. 2017 Mar 30;376(13):1292-1294. doi: 10.1056/NEJMc1612455. No abstract available.

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• Waldner MJ, Knieling F, Egger C, Morscher S, Claussen J, Vetter M, Kielisch C, Fischer S, Pfeifer L, Hagel A, Goertz RS, Wildner D, Atreya R, Strobel D, Neurath MF. Multispectral Optoacoustic Tomography in Crohn's Disease: Noninvasive Imaging of Disease Activity. Gastroenterology. 2016 Aug;151(2):238-40. doi: 10.1053/j.gastro.2016.05.047. Epub 2016 Jun 3. No abstract available.

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• Sou S, Matsui T, Yao T, Naito M, Yorioka M, Beppu T, Nagahama T, Futami K. Differentiating enterocutaneous fistulae from suture abscesses complicating Crohn's disease using oral administration of indocyanine green. J Gastroenterol Hepatol. 2006 Dec;21(12):1850-3. doi: 10.1111/j.1440-1746.2006.04287.x.

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• Bennink R, Peeters M, Van den Maegdenbergh V, Geypens B, Rutgeerts P, De Roo M, Mortelmans L. Evaluation of small-bowel transit for solid and liquid test meal in healthy men and women. Eur J Nucl Med. 1999 Dec;26(12):1560-6. doi: 10.1007/s002590050495.

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• Camilleri M, Colemont LJ, Phillips SF, Brown ML, Thomforde GM, Chapman N, Zinsmeister AR. Human gastric emptying and colonic filling of solids characterized by a new method. Am J Physiol. 1989 Aug;257(2 Pt 1):G284-90. doi: 10.1152/ajpgi.1989.257.2.G284.

  PMID: 2764112 BACKGROUND

MeSH Terms

Conditions

Digestive System Diseases; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A comparison is made between 3 study arms: A: Fasting, B: Standardised breakfast, C: Standardised breakfast with added ICG (250mg in 50ml aqua). As part of the crossover design, each participant will be assigned to all three study arms on three different days. There is a period of at least 48 hours between two consecutive study days for each subject.

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 16, 2021
• Study Start: November 23, 2021
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2022
• Last Updated: July 19, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request as follows: * Individual participant data will not be available * Study Protocol Plan will be available * The data will be available beginning 9 months and ending 36 months following article publication. * The data will be available to researchers who provide a methodologically sound proposal. * The data will be available for individual participant data meta-analysis, only. * Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at www.uk-erlangen.de. Restrictions may apply due to patient privacy and the General Data Protection Regulation.

Locations

DE (1)