VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients

Recruiting now

Conditions studied: Hepatic Disorders, Intestinal Failure-associated Liver Disease, Cystic Fibrosis Liver Disease, MAFLD, Pediatric Liver Transplantation

In brief

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?

Key facts

Study ID

NCT07202910

Run by

Sahlgrenska University Hospital

People needed

550

Starts

2019-03-28

Expected to finish

2032-12-01

Last updated by the study team

2025-10-02

Who can join

Age: any, up to 25. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• technical limitations regarding the measurements
• inability to fully understand the informed consent documents.

Where it is running

• Department of Radiology, Queen Silvias Children´s Hospital,Gothenburg Sweden — Gothenburg, Västra Götaland County, Sweden (enrolling)

Full record on ClinicalTrials.gov

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