Imaging-Based Biomarkers for Non-Invasive Pediatric Liver Diagnostics

Registration

Registration

NCT07202910

Acronym

VALiBi-PED

Study type

OBSERVATIONAL

Status

RECRUITING

Enrollment

550

Start

2019-03-28

Primary completion

2030-03

Lead sponsor

Sahlgrenska University Hospital

Conditions

Hepatic Disorders; Intestinal Failure-associated Liver Disease; Cystic Fibrosis Liver Disease; MAFLD; Pediatric Liver Transplantation

Results posted

FALSE

Individual participant data sharing

NO

Secondary identifiers

OTHER_GRANT:Dnr 2023-01951; OTHER_GRANT:ALFGBG-1005247

Registered primary outcomes

• Diagnostic accuracy of ultrasound-based liver biomarkers (SWE, SWD, ATI) (STUDY 1) [At time of liver biopsy]
• Longitudinal change in SWE/SWD/ATI biomarkers before and after treatment with CFTR modulators, (Study 2A - Children with Cystic Fibrosis) [baseline (pretreatment) up to 2 years]
• Change in liver biomarkers measured by SWE and SWD during routine ultrasound surveillance post-liver transplantation. (Study 2b) [Up to 1 year]
• Detection of early liver damage using SWE, SWD, and ATI (Attenuation Imaging) in children with intestinal failure. (Study 2c) [up to 2 years]
• Change in SWE/SWD/ATI biomarkers following obesity treatment (GLP-1 analogues or bariatric surgery) (Study2d) [through study completion, an average of 1 years]
• Correlation between ultrasound biomarkers and MR biomarkers . (Study 3) [periprocedurally]