NCT07202910 VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients
| NCT ID | NCT07202910 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sahlgrenska University Hospital |
| Condition | Hepatic Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 550 participants |
| Start Date | 2019-03-28 |
| Primary Completion | 2030-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 550 participants in total. It began in 2019-03-28 with a primary completion date of 2030-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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?
Eligibility 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.
Contact & Investigator
Hanna Hebelka
PRINCIPAL INVESTIGATOR
Institute of clinical sciences, Sahlgrenska Academy, Gothenburg University
Frequently Asked Questions
Who can join the NCT07202910 clinical trial?
This trial is open to participants of all sexes, up to 25 Years, studying Hepatic Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07202910 currently recruiting?
Yes, NCT07202910 is actively recruiting participants. Contact the research team at hanna.hebelka@vgregion.se for enrollment information.
Where is the NCT07202910 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT07202910 clinical trial?
NCT07202910 is sponsored by Sahlgrenska University Hospital. The principal investigator is Hanna Hebelka at Institute of clinical sciences, Sahlgrenska Academy, Gothenburg University. The trial plans to enroll 550 participants.