Using ultrasound-based measures to check liver health in children
Imaging-Based Biomarkers for Non-Invasive Pediatric Liver Diagnostics
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | N/A to 25 Years |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Locations | 1 site (Gothenburg, Västra Götaland County) |
| Trial ID | NCT07202910 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gothenburg, Västra Götaland County
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.