Using advanced imaging to assess liver and gastrointestinal issues in cystic fibrosis patients
Multispectral Optoacoustic Tomography for the Assessment of Liver Fibrosis and Gastrointestinal Transit in Patients With Cystic Fibrosis
This study is testing a new imaging technique to see how cystic fibrosis affects the liver and digestive system in adults, helping to catch any problems early.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Erlangen, Bavaria) |
| Trial ID | NCT06063785 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the degree of liver fibrosis and gastrointestinal passage in adult patients with cystic fibrosis using Multispectral Optoacoustic Imaging (MSOT). The study aims to identify early signs of liver disease and gastrointestinal disorders associated with cystic fibrosis, which can lead to serious complications if not detected early. Participants will undergo non-invasive imaging techniques to evaluate liver health and gastrointestinal function. The study includes patients with and without CF-related liver disease, ensuring a comprehensive understanding of the condition's impact.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a confirmed diagnosis of cystic fibrosis, both with and without CF-related liver disease.
Not a fit: Patients who are pregnant, breastfeeding, or have certain skin conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of liver and gastrointestinal complications in cystic fibrosis patients.
How similar studies have performed: Other studies using imaging techniques for assessing liver fibrosis in cystic fibrosis have shown promise, but the use of MSOT in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Erlangen, Bavaria
- University Hospital Erlange, Department of Pediatrics — Erlangen, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Alexander Schnell — Department of Pediatric and Adolescent Medicine, University Hospital Erlangen
- Study coordinator: Alexander Schnell
- Email: alexander.schnell@uk-erlangen.de
- Phone: +4991318533118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.