Clinical trial Recruiting at 1 site Observational Ages Any age to 25

Using ultrasound-based measures to check liver health in children

Official title: Imaging-Based Biomarkers for Non-Invasive Pediatric Liver Diagnostics

Run by Sahlgrenska University Hospital · NCT07202910 · Data updated 2026-11-12

This project will test whether ultrasound techniques like shear wave elastography, shear wave dispersion, and attenuation imaging can noninvasively characterize liver disease in children who have or may have liver problems.

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Quick facts

Study typeObservational
AgesAny age to 25 Years
SexAll
Enrollment550 (estimated)
SponsorSahlgrenska University Hospital
Academic / other
Locations1 site (Gothenburg, Västra Götaland County)
StatusRecruiting
StartedMarch 28, 2019
Main results expectedMarch 2030
Study endsDecember 2032
Registry record updatedOctober 2, 2025
Trial IDNCT07202910 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 0–18 with suspected or confirmed liver disease who are scheduled for a clinically indicated liver biopsy at Queen Silvia Children's Hospital (and control children scheduled for renal biopsy) are the ideal candidates.

Probably not a fit

Children not undergoing biopsy, adults, or patients in whom imaging cannot be performed due to technical limitations or inability to consent are unlikely to receive direct benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational diagnostic validation project compares multiple novel ultrasound-based imaging biomarkers with liver biopsy findings in children aged 0–18 to determine how well the imaging methods detect fibrosis, inflammation, and steatosis. The protocol includes a main cross-sectional comparison at the time of clinically indicated liver biopsy and control subjects undergoing renal biopsy, plus longitudinal follow-up in groups such as liver transplant recipients, children with cystic fibrosis, obesity-associated liver disease, and intestinal failure-associated liver disease. Specific aims include establishing quantitative cutoffs for imaging measures, exploring interactions with clinical and laboratory factors (age, sex, BMI, cholestasis, etc.), and testing whether the imaging markers improve disease surveillance versus conventional ultrasound and blood tests. The study is conducted at Queen Silvia Children's Hospital within Sahlgrenska University Hospital in Gothenburg, Sweden.

Why it matters

Potential benefit: If successful, these imaging biomarkers could reduce the need for liver biopsies and improve noninvasive monitoring of pediatric liver disease.

How similar studies have gone: Ultrasound elastography and attenuation techniques have shown promise in adults and in smaller pediatric series, but comprehensive validation against liver biopsy across diverse pediatric liver conditions remains limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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's running

  • Department of Radiology, Queen Silvias Children´s Hospital,Gothenburg Sweden
    Gothenburg, Västra Götaland County, Sweden
    Recruiting

Study contacts

  • Principal investigator: Hanna Hebelka — Institute of clinical sciences, Sahlgrenska Academy, Gothenburg University
  • Study coordinator: Hanna M Hebelka, Associate Prof.
  • Email: hanna.hebelka@vgregion.se
  • Phone: +46705667867

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.