Status:
RECRUITING
VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients
Lead Sponsor:
Sahlgrenska University Hospital
Collaborating Sponsors:
Queen Silvia Children's Hospital, Gothenburg, Sweden
Conditions:
Hepatic Disorders
Intestinal Failure-associated Liver Disease
Eligibility:
All Genders
Up to 25 years
Brief 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. ...
Detailed Description
The purpose is to improve diagnostics and surveillance in children with liver disease and reduce the need for biopsies. The overall aim is to test the hypothesis that multiple novel imaging-based biom...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 28 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2032
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT07202910
Start Date
March 28 2019
End Date
December 1 2032
Last Update
October 2 2025
Active Locations (1)
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1
Department of Radiology, Queen Silvias Children´s Hospital,Gothenburg Sweden
Gothenburg, Västra Götaland County, Sweden, 41650