Status:
UNKNOWN
Multispectral Optoacoustic Tomography in Patients With Cystic Fibrosis
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Collaborating Sponsors:
Adrian Regensburger
Conditions:
Cystic Fibrosis
Liver Fibrosis
Eligibility:
All Genders
18+ years
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, ...
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 inherit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06063785
Start Date
October 1 2023
End Date
March 31 2025
Last Update
October 23 2023
Active Locations (1)
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1
University Hospital Erlange, Department of Pediatrics
Erlangen, Bavaria, Germany, 91054