VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients
Recruiting · NCT07202910 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sahlgrenska University Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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?
Who can take part
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.
Where it is running
1 location listed.
- Department of Radiology, Queen Silvias Children´s Hospital,Gothenburg Sweden - Gothenburg, Västra Götaland County, Sweden