Cross-sectional Study for Assessment of MRI Based Biomarkers of Bile Duct Injury and Hepatic Fibrosis in Pediatric Onset Autoimmune Liver Disease
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 23
Healthy Volunteers: f
View:
• Age 6-23 years old.
• Established or suspected clinical diagnosis of AIH or PSC.
Locations
United States
Ohio
Cincinnati Childrens Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Alexander Miethke, MD
Alexander.Miethke@cchmc.org
513-636-8948
Backup
Cyd Castro Rojas, PhD
Cyd.CastroRojas@cchmc.org
513-517-0580
Time Frame
Start Date:2017-01-17
Estimated Completion Date:2027-01-30
Participants
Target number of participants:115
Treatments
Patients with autoimmune liver disease
Patients (6-23 y.o.) with established clinical diagnosis of AIH or suspected diagnosis of AIH based on elevated serum AST or ALT, elevated IgG level \>1.1 ULN, elevated titer of autoantibodies, including ANA, SMA, LKM, LC-1 or SLA, which is consistent with the simplified criteria for the diagnosis of AIH in children will be enrolled.~Patients (6-23 y.o.) with established clinical diagnosis of PSC or Suspected diagnosis of PSC supported by abnormal cholangiogram (ERCP or MRCP) or elevated GGT\>1.5 ULN and dilated bile ducts by liver ultrasound will be enrolled.