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Recruiting NCT07202910

VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients

Trial Parameters

Condition Hepatic Disorders
Sponsor Sahlgrenska University Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 550
Sex ALL
Min Age N/A
Max Age 25 Years
Start Date 2019-03-28
Completion 2030-03

Brief Summary

The goal of this observational (diagnostic validation) study is to validate imaging-based biomarkers for assessing liver involvement in pediatric patients with established or suspected liver disease. The projekt involves 3 larger studies, each with specific aims specified in detailed description below. The main study (study 1) compares imaging-based biomarkers-with liver biopsy to evaluate their correlation with histologically confirmed liver disease, including fibrosis, inflammation, and steatosis. The main question the overall project aims to answer is: • Can multiple novel imaging-based biomarkers, such as shear wave elastography (SWE), shear wave dispersion (SWD), and attenuation imaging (ATI), be used for detailed, non-invasive liver characterization in children, and if so, how should they be used?

Eligibility Criteria

Inclusion Criteria (Study 1-main study) * all patients scheduled for a clinically liver biopsy at the Queen Silvia Children's Hospital * any form of suspected or confirmed liver disease * age between 0-18 years * consent by the child/parents to participate. * For controls: children scheduled for a renal biopsy * age between 0-18 years * consent by the child/parents to participate. Exclusion Criteria: * technical limitations regarding the measurements * inability to fully understand the informed consent documents.

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