Multispectral Optoacoustic Tomography in Patients With Cystic Fibrosis
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedFirst Posted
Study publicly available on registry
October 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedOctober 23, 2023
October 1, 2023
1 year
September 5, 2023
October 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Quantitative collagen signal (Liver)
in arbitrary units
Day 1
Quantitative Indocyanine Green (ICG) signal (Intestinal)
Day 1
0, 60, 90, 120, 180, 240, 300min post ICG intake
Secondary Outcomes (13)
Quantitative oxy/deoxygenated hemoglobin signal (Liver)
Day 1
Quantitative oxy/deoxygenated hemoglobin signal (Intestinal)
0, 60, 90, 120, 180, 240, 300min post ICG intake
Quantitative single wave lengths (Intestinal)
0, 60, 90, 120, 180, 240, 300min post ICG intake
Quantitative single wave lengths (Liver)
Day 1
Optoacoustic spectrum (Intestinal)
0, 60, 90, 120, 180, 240, 300min post ICG intake
- +8 more secondary outcomes
Study Arms (3)
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
Interventions
Measurement of Liver stiffness
Measurement of optoacoustic spectra in liver and gastrointestinal tract
Eligibility Criteria
It is planned to study a total of 10 patients each with cystic fibrosis with/without CF-related liver disease and 10 healthy volunteers.
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Erlange, Department of Pediatrics
Erlangen, Bavaria, 91054, Germany
Biospecimen
Serum samples for bile acid profiling Stool samples for bile acid profiling
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Schnell
Department of Pediatric and Adolescent Medicine, University Hospital Erlangen
- PRINCIPAL INVESTIGATOR
Adrian P Regensburger
Department of Pediatric and Adolescent Medicine, University Hospital Erlangen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 5, 2023
First Posted
October 3, 2023
Study Start
October 1, 2023
Primary Completion
September 30, 2024
Study Completion
March 31, 2025
Last Updated
October 23, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share