VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 25
SponsorSahlgrenska University Hospital

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

Sponsors and collaborators

Sahlgrenska University Hospital

Lead sponsor

Queen Silvia Children's Hospital, Gothenburg, Sweden

Collaborator