About this trial

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

Qualifiers

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.

Disqualifiers

technical limitations regarding the measurements

inability to fully understand the informed consent documents.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

550 Participants
are grouped into 3 trial groups

Locations

1
Department of Radiology, Queen Silvias Children´s Hospital,Gothenburg Sweden41650, GothenburgVästra Götaland County, Sweden

Sponsors and collaborators

Sahlgrenska University Hospital

Lead sponsor

Queen Silvia Children's Hospital, Gothenburg, Sweden

Collaborator