NCT03746210

Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Bonn · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhoses

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Standard diagnostic procedures	B-Mode ultrasound, Duplex sonography, contrast-enhanced ultrasound, elastography, CT, MRI, anthropometrics

Timeline

• Start date: 2016-01-01
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2018-11-19
• Last updated: 2022-05-18

Locations

1 site across 1 country: Germany