MRI Based Biomarkers in Pediatric Autoimmune Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Autoimmune Liver Disease, Primary Sclerosing Cholangitis, Autoimmune Hepatitis. Basic parameters: 6 years — 23 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cross-sectional Study for Assessment of MRI Based Biomarkers of Bile Duct Injury and Hepatic Fibrosis in Pediatric Onset Autoimmune Liver Disease
Overview
Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factors for chronic liver disease among adolescents. In all these conditions, autoimmune lymphocyte responses are thought to orchestrate inflammatory injury against hepatocytes (primarily in AIH) or cholangiocytes (in PSC). In this proposal we aim to evaluate the Magnetic Resonance Imaging (MRI) modalities; MR cholangiopancreatography (MRCP) and MR elastography (MREL), as non-invasive biomarkers to assess two primary pathophysiological processes of AILD: bile duct damage and liver fibrosis. In this cross-sectional study MRI based findings of bile duct injury and liver fibrosis will be correlated with both liver histology and circulating biomarkers of these disease processes.
Primary outcome measures
- MRI based outcomes [Time frame: 36 months]
- Liver histopathology based assessment of bile duct injury by ISHAK Score [Time frame: 36 months]
- Liver histopathology based assessment of bile duct injury by Ludwig score [Time frame: 36 months]
- Liver histopathology based assessment of liver fibrosis by Nakanuma score [Time frame: 36 months]
- Liver histopathology based assessment of liver fibrosis by Ishak score [Time frame: 36 months]
- Liver histopathology based assessment of cholangitis and hepatic activity [Time frame: 36 months]
- Serum based outcome [Time frame: 36 months]
- Enhanced Liver Fibrosis (ELF) score [Time frame: 36 months]
Secondary outcome measures (5)
- MR T1rho, T1, T2 Imaging [Time frame: 36 Months]
- Liver Morphometry [Time frame: 36 Months]
- Liver histopathology based outcomes [Time frame: 36 Months]
- Serum based outcomes [Time frame: 36 Months]
- Serum MMP7 [Time frame: 36 Months]
Eligibility criteria
Inclusion criteria
- Age 6-23 years old.
- Established or suspected clinical diagnosis of AIH or PSC.
Exclusion criteria
- History of liver transplantation.
- Chronic Hepatitis B or untreated hepatitis C virus infection.
- Pregnancy.
- Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).
- Diagnosis of cystic fibrosis or biliary atresia
- Diagnosis of cardiac hepatopathy.
- Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease.
- Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Cincinnati Childrens Hospital Medical Center — Cincinnati
Publications
- Mahalingam N, Trout AT, Zhang B, Castro-Rojas C, Miethke AG, Dillman JR. Longitudinal changes in quantitative magnetic resonance imaging metrics in children and young adults with autoimmune liver disease. Abdom Radiol (NY). 2023 Jun;48(6):1933-1944. doi: 10.1007/s00261-022-03733-9. Epub 2023 Feb 17. PMID 36799997
- McCrary J, Trout AT, Mahalingam N, Singh R, Rojas CC, Miethke AG, Dillman JR. Associations Between Quantitative MRI Metrics and Clinical Risk Scores in Children and Young Adults With Autoimmune Liver Disease. AJR Am J Roentgenol. 2022 Jul;219(1):142-150. doi: 10.2214/AJR.21.27204. Epub 2022 Jan 26. PMID 35080454
- Dillman JR, Trout AT, Taylor AE, Khendek L, Kasten JL, Sheridan RM, Sharma D, Karns RA, Castro-Rojas C, Zhang B, Miethke AG. Association Between MR Elastography Liver Stiffness and Histologic Liver Fibrosis in Children and Young Adults With Autoimmune Liver Disease. AJR Am J Roentgenol. 2024 Jul;223(1):e2431108. doi: 10.2214/AJR.24.31108. Epub 2024 Apr 17. PMID 38630086
Identifiers
NCT: NCT03175471 · CIN001-MRI biomarkers in AILD