Multispectral Optoacoustic Tomography in Patients With Cystic Fibrosis (NCT06063785) | Clinical Trial Compass
UnknownNot Applicable
Multispectral Optoacoustic Tomography in Patients With Cystic Fibrosis
Germany30 participantsStarted 2023-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantitative collagen signal (Liver)
Timeframe: Day 1
2
Quantitative Indocyanine Green (ICG) signal (Intestinal)