Imaging-Based Biomarkers for Non-Invasive Pediatric Liver Diagnostics

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 25
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Sweden
Department of Radiology, Queen Silvias Children´s Hospital,Gothenburg Sweden
RECRUITING
Gothenburg
Contact Information
Primary
Hanna M Hebelka, Associate Prof.
hanna.hebelka@vgregion.se
+46705667867
Backup
Charlotte de Lange, Assoc.Prof.
charlotte.de.lange@vgregion.se
+46735367199
Time Frame
Start Date: 2019-03-28
Estimated Completion Date: 2032-12
Participants
Target number of participants: 550
Treatments
Children with established or suspected liver disease
Study 1: All children with suspected or established liver disease referred for at liver biopsy at Queen Silvias Children Hospital during the inclusion period. Their ultrasound based biomarkers will be compared with histology and with ultrasound biomarkers of controls (children without liver disease or conditions affecting the liver, referred for a renal biopsy during the inclusion period)
Children who need surveillance of disease and treatment by longitudinal monitoring
Study 2: Several diseases/conditions are already monitored with conventional ultrasound on a regular basis in children. Examples include cystic fibrosis, liver transplants, severe obesity and failure-associated liver disease (IFALD).
Children with MR of the liver
This study (study 3) cohort will include around 50 children who are participating in study 1 and 2, and in whom MRI is clinically indicated as a supplement to ultrasound examination - for example, children with obesity for whom ultrasound may be insufficient or children in whom a more global characterization of the liver is desired.
Sponsors
Collaborators: Queen Silvia Children's Hospital, Gothenburg, Sweden
Leads: Sahlgrenska University Hospital

This content was sourced from clinicaltrials.gov