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NCT03746210 Clinical Trial

Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis

Liver Cirrhoses Clinical Trial

— NICETIES  

Official title:
Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03746210
Other study ID # NICETIES
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2027

Study information
Verified date May 2022
Source University Hospital, Bonn
Contact Michael Praktiknjo, MD
Phone +4922828715770
Email michael.praktiknjo@ukbonn.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2027
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - all patients with focal liver lesions and liver cirrhosis Exclusion Criteria: - no consent - under 18 years

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany University Hospital Bonn Bonn

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy The diagnostic accuracy of non-invasive imaging of focal liver lesions in liver cirrhosis compared to gold standard (histology, CT and/or MRI) 1 year
Secondary Predictive Value The predictive value on mortality and treatment response of non-invasive imaging of focal liver lesions in liver cirrhosis up to 5 years
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