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NCT07202910Recruiting

VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients

Imaging-Based Biomarkers for Non-Invasive Pediatric Liver Diagnostics

Source: ClinicalTrials.gov · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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?

Status (registry)
Recruiting
Study type
Observational
Enrollment
550 (estimated)
First submitted
16 Sept 2025
Start date
28 Mar 2019
Primary completion date
Mar 2030
Lead sponsor
Sahlgrenska University Hospital
NCT number
NCT07202910

What you commit to

  • Study type: Observational
  • Planned participants: 550
  • From 28 Mar 2019 to the primary completion date, Mar 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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.

Age in the registry: - to 25 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Radiology, Queen Silvias Children´s Hospital,Gothenburg Sweden
Coordinator of this site? Confirm its status
GothenburgSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.