Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03746210

Acronym

NICETIES

Enrollment

200

Registered

2018-11-19

Start date

2016-01-01

Completion date

2027-12-31

Last updated

2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhoses

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.

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.

Interventions

DIAGNOSTIC_TESTStandard diagnostic procedures

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* all patients with focal liver lesions and liver cirrhosis

Exclusion criteria

* no consent * under 18 years

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy	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

Measure	Time frame	Description
Predictive Value	up to 5 years	The predictive value on mortality and treatment response of non-invasive imaging of focal liver lesions in liver cirrhosis

Countries

Germany

Contacts

Primary ContactMichael Praktiknjo, MD

michael.praktiknjo@ukbonn.de+4922828715770

Backup ContactJohannes Chang, MD

johannes.chang@ukbonn.de+4922828715770

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026