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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

∙ 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

Locations
Other Locations
Germany
University Hospital Erlange, Department of Pediatrics
RECRUITING
Erlangen
Contact Information
Primary
Alexander Schnell
alexander.schnell@uk-erlangen.de
+4991318533118
Backup
Adrian P Regensburger
adrian.regensburger@uk-erlangen.de
+4991318533118
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 30
Treatments
CF with liver affection
CF patients with proven CF hepatopathy
CF without liver affection
CF patients without proven CF hepatopathy
Healthy volunteers
Healthy volunteers without liver affection
Related Therapeutic Areas
Sponsors
Collaborators: Adrian Regensburger
Leads: University of Erlangen-Nürnberg Medical School

This content was sourced from clinicaltrials.gov