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 : April 28, 2021
|Condition or disease||Intervention/treatment|
|Liver Cirrhoses||Diagnostic Test: Standard diagnostic procedures|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
- Diagnostic Test: Standard diagnostic procedures
B-Mode ultrasound, Duplex sonography, contrast-enhanced ultrasound, elastography, CT, MRI, anthropometrics
- 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)
- 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
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
|Contact: Michael Praktiknjo, MDfirstname.lastname@example.org|
|Contact: Johannes Chang, MDemail@example.com|