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NCT Number: NCT03746210

Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis

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.

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Key information

Conditions

Liver Cirrhoses

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients with focal liver lesions and liver cirrhosis

Exclusion criteria

  • no consent
  • under 18 years

Treatment and study plan

Standard diagnostic procedures

Diagnostic Test

B-Mode ultrasound, Duplex sonography, contrast-enhanced ultrasound, elastography, CT, MRI, anthropometrics

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Chang, MD

CONTACT

[email protected]

+4922828715770

Michael Praktiknjo, MD

CONTACT

[email protected]

+4922828715770

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Acronym: NICETIES

Important dates

Study start
2016
Primary completion
2025
Study completion
2027
First posted
Nov 19, 2018
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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