Cystic Fibrosis Clinical Trial
Official title:
Multispectral Optoacoustic Tomography for the Assessment of Liver Fibrosis and Gastrointestinal Transit in Patients With Cystic Fibrosis
NCT number | NCT06063785 |
Other study ID # | CF_MSOT |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2023 |
Est. completion date | March 31, 2025 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | March 31, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Erlange, Department of Pediatrics | Erlangen | Bavaria |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School | Adrian Regensburger |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantitative collagen signal (Liver) | in arbitrary units | Day 1 | |
Primary | Quantitative Indocyanine Green (ICG) signal (Intestinal) | Day 1 | 0, 60, 90, 120, 180, 240, 300min post ICG intake | |
Secondary | Quantitative oxy/deoxygenated hemoglobin signal (Liver) | in arbitrary units | Day 1 | |
Secondary | Quantitative oxy/deoxygenated hemoglobin signal (Intestinal) | in arbitrary units | 0, 60, 90, 120, 180, 240, 300min post ICG intake | |
Secondary | Quantitative single wave lengths (Intestinal) | in arbitrary units | 0, 60, 90, 120, 180, 240, 300min post ICG intake | |
Secondary | Quantitative single wave lengths (Liver) | in arbitrary units | Day 1 | |
Secondary | Optoacoustic spectrum (Intestinal) | in arbitrary units, normalized | 0, 60, 90, 120, 180, 240, 300min post ICG intake | |
Secondary | Optoacoustic spectrum (Liver) | in arbitrary units, normalized | Day 1 | |
Secondary | Shear wave velocity (Liver) | in m/s | Day 1 | |
Secondary | Attenuation coefficient (Liver) | in dB/cm/MHz | Day 1 | |
Secondary | Chenodeoxycholic acid (CDCA) and respective glycine and taurine conjugates | µmol/l and /g stool | Day 1 | |
Secondary | Cholic acid (CA) and respective glycine and taurine conjugates | µmol/l and /g stool | Day 1 | |
Secondary | Deoxycholic acid (DCA) and respective glycine and taurine conjugates | µmol/l and /g stool | Day 1 | |
Secondary | Lithocholic acid (LCA) and respective glycine and taurine conjugates | µmol/l and /g stool | Day 1 | |
Secondary | Ursodeoxycholic acid (UDCA) and respective glycine and taurine conjugates | µmol/l and /g stool | Day 1 |
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