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Multispectral Optoacoustic Tomography in Patients With Cystic Fibrosis

Multispectral Optoacoustic Tomography for the Assessment of Liver Fibrosis and Gastrointestinal Transit in Patients With Cystic Fibrosis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06063785
Enrollment
30
Registered
2023-10-03
Start date
2023-10-01
Completion date
2025-03-31
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Dios, Gastrointestinal Transport Disorder, Liver Fibrosis

Keywords

Cystic Fibrosis, MSOT, Liver Fibrosis, Gastrointestinal Transit

Brief summary

Cystic fibrosis (CF) is the most common hereditary disease in Central Europe. The disease is caused by a mutation in the cystic fibrosis transmembrane conductance regulator gene (CFTR). In the liver, fibrotic remodeling can lead to liver cirrhosis in the long term. Early detection of CF hepatopathy is essential to therapeutically slow down the progression of fibrotic remodeling mechanisms. Newborns suffering from CF have a significantly increased risk for the occurrence of meconium ileus and also with advancing age there are symptoms ranging from chronic constipation to Distal Intestinal Obstruction Syndrome (DIOS), due to a reduction of intestinal motility. In this study, the degree of liver fibrosis will now be investigated in adult patients with cystic fibrosis using Multispectral Optoacoustic Imaging (MSOT). In addition, gastrointestinal passage will be studied non-invasively to investigate another affection of the gastrointestinal system.

Detailed description

Cystic fibrosis (CF) is the most common hereditary disease in Central Europe, with an incidence of approximately 3,300 to 4,800 new cases. The disease follows an autosomal recessive pattern of inheritance, the cause being a mutation in the cystic fibrosis transmembrane conductance regulator gene (CFTR). In the liver, fibrotic remodeling can lead to liver cirrhosis in the long term. Early detection of CF hepatopathy is essential to therapeutically slow down the progression of fibrotic remodeling mechanisms. Over the past decade, measurements of liver stiffness using Acoustic Radiation Force Impulse Imaging (ARFI) have proven to be a valid tool for measuring fibrotic tissue remodeling in CF in adults and children. Furthermore, in the gastrointestinal tract, serious consequences result from the absence of the CFTR channel. Newborns suffering from CF have a significantly increased risk for the occurrence of meconium ileus and also with advancing age there are symptoms ranging from chronic constipation to DIOS (Distal Intestinal Obstruction Syndrome), due to a reduction of intestinal motility. By means of new imaging methods, such as multispectral optoacoustic tomography, it is possible to examine not only the body's own substances but also substances foreign to the body. With Multispectral Optoacoustic Imaging (MSOT), similar to conventional sonography, a transducer is placed on the skin and instead of sound, energy is applied to the tissue by means of light flashes. This leads to a constant alternation of minimal expansions and contractions (thermoelastic expansion) of individual tissue components or molecules. Previous studies have shown that quantitative determination of hemoglobin can provide information on blood flow and inflammatory activity in the intestines of adult patients with Crohn's disease. Also, fibrotic changes in the liver can probably be detected with this method, similar to that in muscle tissue. Furthermore, we have recently shown that orally ingested Indocyanine green (ICG) can be detected in the small intestine and thus conclusions can be drawn about gastrointestinal passage, without the use of ionizing radiation. In this study, the degree of liver fibrosis will now be investigated in adult patients with cystic fibrosis using MSOT. In addition, gastrointestinal passage will be studied non-invasively to investigate another affection of the gastrointestinal system.

Interventions

DIAGNOSTIC_TESTAcoustic Radiation Forced Impulse Imaging

Measurement of Liver stiffness

Measurement of optoacoustic spectra in liver and gastrointestinal tract

Sponsors

Adrian Regensburger
CollaboratorUNKNOWN
University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Patient cohort Cystic Fibrosis without CF-related liver disease: * Molecular genetic confirmed diagnosis of cystic fibrosis. * Age over 18 years * Written informed consent Patient cohort Cystic Fibrosis with CF-related liver disease: * Molecular genetic confirmed diagnosis of cystic fibrosis * Presence of CF-related liver disease based on Colombo criteria: * Hepato- and/or splenomegaly * Persistent elevation of transaminases in the serum * Sonographic evidence of liver involvement * Age over 18 years * Written informed consent Volunteer Subjects: * 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 Patient cohort Cystic fibrosis without CF-related liver disease: * Taking systemic glucocorticoids or immunosuppressants as part of a permanent medication regimen. * Presence of CF-related liver disease based on Colombo criteria: * Hepato- and/or splenomegaly. * Persistent elevation of transaminases in the serum * Sonographic evidence of liver involvement. * Acute exacerbation of infection Patient cohort Cystic fibrosis with CF-related liver disease: * Taking systemic glucocorticoids or immunosuppressants as part of a permanent medication regimen. * Decompensation of CF-related liver disease * Acute exacerbation of infection volunteer subjects: * Presence of liver disease * Use of systemic glucocorticoids or immunosuppressants in the context of permanent medication

Design outcomes

Primary

MeasureTime frameDescription
Quantitative collagen signal (Liver)Day 1in arbitrary units
Quantitative Indocyanine Green (ICG) signal (Intestinal)0, 60, 90, 120, 180, 240, 300min post ICG intakeDay 1

Secondary

MeasureTime frameDescription
Quantitative single wave lengths (Intestinal)0, 60, 90, 120, 180, 240, 300min post ICG intakein arbitrary units
Quantitative single wave lengths (Liver)Day 1in arbitrary units
Optoacoustic spectrum (Intestinal)0, 60, 90, 120, 180, 240, 300min post ICG intakein arbitrary units, normalized
Optoacoustic spectrum (Liver)Day 1in arbitrary units, normalized
Shear wave velocity (Liver)Day 1in m/s
Quantitative oxy/deoxygenated hemoglobin signal (Liver)Day 1in arbitrary units
Chenodeoxycholic acid (CDCA) and respective glycine and taurine conjugatesDay 1µmol/l and /g stool
Cholic acid (CA) and respective glycine and taurine conjugatesDay 1µmol/l and /g stool
Deoxycholic acid (DCA) and respective glycine and taurine conjugatesDay 1µmol/l and /g stool
Lithocholic acid (LCA) and respective glycine and taurine conjugatesDay 1µmol/l and /g stool
Ursodeoxycholic acid (UDCA) and respective glycine and taurine conjugatesDay 1µmol/l and /g stool
Attenuation coefficient (Liver)Day 1in dB/cm/MHz
Quantitative oxy/deoxygenated hemoglobin signal (Intestinal)0, 60, 90, 120, 180, 240, 300min post ICG intakein arbitrary units

Countries

Germany

Contacts

Primary ContactAlexander Schnell
alexander.schnell@uk-erlangen.de+4991318533118
Backup ContactAdrian P Regensburger
adrian.regensburger@uk-erlangen.de+4991318533118

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026