Longitudinal changes in quantitative magnetic resonance imaging metrics in children and young adults with autoimmune liver disease.
Neeraja Mahalingam, Andrew T Trout, Bin Zhang...
https://pubmed.ncbi.nlm.nih.gov/36799997Actively Recruiting
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2024-12-12
115
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are studying autoimmune liver diseases (AILD), including Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH), which commonly cause chronic liver disease in adolescents. These diseases involve immune system attacks on liver cells or bile ducts, causing inflammation and damage. The study aims to evaluate non-invasive MRI techniques, specifically MR cholangiopancreatography (MRCP) and MR elastography (MREL), as biomarkers to assess bile duct damage and liver fibrosis in these conditions. Participants include children and young adults aged 6 to 23 years with either confirmed or suspected diagnoses of AIH or PSC based on clinical and laboratory criteria. The study is cross-sectional and involves MRI scans to detect bile duct injury and liver fibrosis. MRI findings will be compared with liver biopsy results and blood tests that reflect disease activity. This approach helps understand how well MRI can serve as a non-invasive tool for disease assessment. During the study, participants will undergo MRI imaging along with blood tests and liver histology evaluations. Researchers will measure liver fibrosis and bile duct injury using established scoring systems from biopsy samples and compare these with MRI and blood markers. The study will track various MRI and serum outcomes over 36 months to assess the relationship between imaging results and disease severity. This ongoing research aims to improve non-invasive monitoring of pediatric autoimmune liver diseases.
CONDITIONS
MRI Based Biomarkers in Pediatric Autoimmune Liver Disease
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 36 months
Participants undergo MRI and liver assessments to evaluate bile duct injury and liver fibrosis.
Periodic imaging and serum assessments during the study period
Duration - Up to 36 months
Participants are monitored over time to observe changes in liver condition using MRI-based biomarkers and serum outcomes.
Ongoing follow-up visits over the 36-month study period
Total: 1 location
1
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
A
Alexander Miethke, MD
C
Cyd Castro Rojas, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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