RecruitingNCT07202910

VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients

Imaging-Based Biomarkers for Non-Invasive Pediatric Liver Diagnostics


Sponsor

Sahlgrenska University Hospital

Enrollment

550 participants

Start Date

Mar 28, 2019

Study Type

OBSERVATIONAL

Conditions

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

Max Age: 25 Years

Inclusion Criteria7

  • 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 Criteria2

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

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Locations(1)

Department of Radiology, Queen Silvias Children´s Hospital,Gothenburg Sweden

Gothenburg, Västra Götaland County, Sweden

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NCT07202910


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