Actively Recruiting

Age: 0 - 25Years
All Genders
Healthy Volunteers
NCT07202910

VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients

Led by Sahlgrenska University Hospital · Updated on 2025-10-02

550

Participants Needed

1

Research Sites

713 weeks

Total Duration

On this page

Sponsors

S

Sahlgrenska University Hospital

Lead Sponsor

Q

Queen Silvia Children's Hospital, Gothenburg, Sweden

Collaborating Sponsor

AI-Summary

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?

CONDITIONS

Official Title

VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients

Who Can Participate

Age: 0 - 25Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for a clinical liver biopsy at Queen Silvia Children's Hospital
  • Children with any form of suspected or confirmed liver disease
  • Age between 0 and 18 years
  • Consent given by the child or parents to participate
  • For controls: children scheduled for a kidney biopsy
  • Age between 0 and 18 years
  • Consent given by the child or parents to participate
Not Eligible

You will not qualify if you...

  • Technical limitations that prevent reliable ultrasound measurements
  • Inability to fully understand the informed consent documents

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Gothenburg, Västra Götaland County, Sweden, 41650

Actively Recruiting

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Research Team

H

Hanna M Hebelka, Associate Prof.

CONTACT

C

Charlotte de Lange, Assoc.Prof.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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