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Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis (NICETIES)

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ClinicalTrials.gov Identifier: NCT03746210
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Praktiknjo, University Hospital, Bonn

Brief Summary:
This study aims to analyze non-invasive characterization focal liver lesions in patients with liver cirrhosis. The diagnostic accuracy and predictive value of non-invasive methods is studied.

Condition or disease Intervention/treatment
Liver Cirrhoses Diagnostic Test: Standard diagnostic procedures

Detailed Description:

This study aims to analyze non-invasive characterization focal liver lesions in patients with liver cirrhosis. The diagnostic accuracy and predictive value of non-invasive methods is studied.

Upon diagnosis multiparametric ultrasound imaging of the lesions as well as sarcopenia parameters are performed for characterization of the lesions. For primary endpoint the results are then analyzed with regard to diagnostic accuracy compared to gold standard (CT, MRI or histology). For secondary endpoint, predictive value of the non-invasive diagnostics are analyzed with regards to mortality and response to treatment.

All work up, treatment and follow up are applied in standard of care fashion.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis


Intervention Details:
  • Diagnostic Test: Standard diagnostic procedures
    B-Mode ultrasound, Duplex sonography, contrast-enhanced ultrasound, elastography, CT, MRI, anthropometrics


Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: 1 year ]
    The diagnostic accuracy of non-invasive imaging of focal liver lesions in liver cirrhosis compared to gold standard (histology, CT and/or MRI)


Secondary Outcome Measures :
  1. Predictive Value [ Time Frame: up to 5 years ]
    The predictive value on mortality and treatment response of non-invasive imaging of focal liver lesions in liver cirrhosis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study includes all adult patients in our institution with liver cirrhosis and diagnosis of focal liver lesions. Non-invasive charaterization (multiparametric ultrasound, sarcopenia assessment) and standard of care work up, treatment and follow up is applied to all patients.
Criteria

Inclusion Criteria:

  • all patients with focal liver lesions and liver cirrhosis

Exclusion Criteria:

  • no consent
  • under 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746210


Contacts
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Contact: Michael Praktiknjo, MD +4922828715770 michael.praktiknjo@ukbonn.de
Contact: Johannes Chang, MD +4922828715770 johannes.chang@ukbonn.de

Locations
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Germany
University Hospital Bonn Recruiting
Bonn, Germany
Contact: Michael Praktiknjo, MD    +49228 28715770    michael.praktiknjo@ukbonn.de   
Contact: Johannes Chang, MD    +49228 28715770    johannes.chang@ukbonn.de   
Sponsors and Collaborators
University Hospital, Bonn

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Responsible Party: Michael Praktiknjo, Principal Investigator / Medical Doctor, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT03746210     History of Changes
Other Study ID Numbers: NICETIES
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases