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VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients

NCT07202910 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 550

Last updated 2025-10-02

No results posted yet for this study

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?

Conditions

  • Hepatic Disorders
  • Intestinal Failure-associated Liver Disease
  • Cystic Fibrosis Liver Disease
  • MAFLD
  • Pediatric Liver Transplantation

Sponsors & Collaborators

  • Queen Silvia Children's Hospital, Gothenburg, Sweden

    collaborator OTHER

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Hanna Hebelka · Institute of clinical sciences, Sahlgrenska Academy, Gothenburg University

Eligibility

Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2030-03-31
Completion
2032-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07202910 on ClinicalTrials.gov