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Cystic FibrosisNCT06063785

Multispectral Optoacoustic Tomography in Patients With Cystic Fibrosis

An observational study of Cystic Fibrosis and Liver Fibrosis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Acoustic Radiation Forced Impulse Imaging and Multispectral Optoacoustic Tomography
How many people
30 participants
Where
1 siteGermany
Study dates
1 Oct 2023to 31 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: It is planned to study a total of 10 patients each with cystic fibrosis with/without CF-related liver disease and 10 healthy volunteers.

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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":
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site, 1 recruiting
  • University Hospital Erlange, Department of Pediatrics

    Erlangen, Bavaria, 91054

    Alexander Schnell, Dr. med., +4991318533118, alexander.schnell@uk-erlangen.de

    Adrian P Regensburger, PD Dr. med., +4991318533118, adrian.regensburger@uk-erlangen.de

    Recruiting

Other trials in Germany

About this study

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

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.

Read the 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 inheritance, the cause being 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. Over the past decade, measurements of liver stiffness using Acoustic Radiation Force Impulse Imaging (ARFI) have proven to be a valid tool for measuring fibrotic tissue remodeling in CF in adults and children. Furthermore, in the gastrointestinal tract, serious consequences result from the absence of the CFTR channel. 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 DIOS (Distal Intestinal Obstruction Syndrome), due to a reduction of intestinal motility.

By means of new imaging methods, such as multispectral optoacoustic tomography, it is possible to examine not only the body's own substances but also substances foreign to the body. With Multispectral Optoacoustic Imaging (MSOT), similar to conventional sonography, a transducer is placed on the skin and instead of sound, energy is applied to the tissue by means of light flashes. This leads to a constant alternation of minimal expansions and contractions (thermoelastic expansion) of individual tissue components or molecules. Previous studies have shown that quantitative determination of hemoglobin can provide information on blood flow and inflammatory activity in the intestines of adult patients with Crohn's disease. Also, fibrotic changes in the liver can probably be detected with this method, similar to that in muscle tissue. Furthermore, we have recently shown that orally ingested Indocyanine green (ICG) can be detected in the small intestine and thus conclusions can be drawn about gastrointestinal passage, without the use of ionizing radiation. In this study, the degree of liver fibrosis will now be investigated in adult patients with cystic fibrosis using MSOT. In addition, gastrointestinal passage will be studied non-invasively to investigate another affection of the gastrointestinal system.

Being tested
Acoustic Radiation Forced Impulse Imaging, Multispectral Optoacoustic Tomography
Keywords
Cystic Fibrosis, MSOT, Liver Fibrosis, Gastrointestinal Transit
Medical subject headings
Cystic Fibrosis, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acoustic Radiation Forced Impulse ImagingDiagnostic test

    Also called ARFI

    Measurement of Liver stiffness

  • Multispectral Optoacoustic TomographyDiagnostic test

    Also called MSOT

    Measurement of optoacoustic spectra in liver and gastrointestinal tract

Study groups in NCT06063785
Study groupRoleWhat they receive
CF with liver affectionCF patients with proven CF hepatopathy
Receives: Diagnostic Test: Acoustic Radiation Forced Impulse Imaging; Diagnostic Test: Multispectral Optoacoustic Tomography
CF without liver affectionCF patients without proven CF hepatopathy
Receives: Diagnostic Test: Acoustic Radiation Forced Impulse Imaging; Diagnostic Test: Multispectral Optoacoustic Tomography
Healthy volunteersHealthy volunteers without liver affection
Receives: Diagnostic Test: Acoustic Radiation Forced Impulse Imaging; Diagnostic Test: Multispectral Optoacoustic Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantitative collagen signal (Liver)

    in arbitrary units

    Measured: Day 1

  2. Quantitative Indocyanine Green (ICG) signal (Intestinal)

    Day 1

    Measured: 0, 60, 90, 120, 180, 240, 300min post ICG intake

Secondary outcomes (13)
  1. Quantitative oxy/deoxygenated hemoglobin signal (Liver)

    in arbitrary units

    Measured: Day 1

  2. Quantitative oxy/deoxygenated hemoglobin signal (Intestinal)

    in arbitrary units

    Measured: 0, 60, 90, 120, 180, 240, 300min post ICG intake

  3. Quantitative single wave lengths (Intestinal)

    in arbitrary units

    Measured: 0, 60, 90, 120, 180, 240, 300min post ICG intake

  4. Quantitative single wave lengths (Liver)

    in arbitrary units

    Measured: Day 1

  5. Optoacoustic spectrum (Intestinal)

    in arbitrary units, normalized

    Measured: 0, 60, 90, 120, 180, 240, 300min post ICG intake

  6. Optoacoustic spectrum (Liver)

    in arbitrary units, normalized

    Measured: Day 1

  7. Shear wave velocity (Liver)

    in m/s

    Measured: Day 1

  8. Attenuation coefficient (Liver)

    in dB/cm/MHz

    Measured: Day 1

  9. Chenodeoxycholic acid (CDCA) and respective glycine and taurine conjugates

    µmol/l and /g stool

    Measured: Day 1

  10. Cholic acid (CA) and respective glycine and taurine conjugates

    µmol/l and /g stool

    Measured: Day 1

  11. Deoxycholic acid (DCA) and respective glycine and taurine conjugates

    µmol/l and /g stool

    Measured: Day 1

  12. Lithocholic acid (LCA) and respective glycine and taurine conjugates

    µmol/l and /g stool

    Measured: Day 1

  13. Ursodeoxycholic acid (UDCA) and respective glycine and taurine conjugates

    µmol/l and /g stool

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2023
  2. Study start1 Oct 2023
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06063785
Sponsor's protocol ID
CF_MSOT
Status last verified
Oct 2023
First submitted
5 Sep 2023
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cystic Fibrosis and Liver Fibrosis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alexander Schnell (+4991318533118, alexander.schnell@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantitative collagen signal (Liver) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

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