What this study is
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.
Study details
- Official title
- Cross-sectional Study for Assessment of MRI Based Biomarkers of Bile Duct Injury and Hepatic Fibrosis in Pediatric Onset Autoimmune Liver Disease
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Autoimmune Liver Disease · Primary Sclerosing Cholangitis · Autoimmune Hepatitis
- Enrolling
- 115 people
- Starts
- 2017-01-17
- Est. completion
- 2030-01-30
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Years – 23 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 6-23 years old.
- Established or suspected clinical diagnosis of AIH or PSC.
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
- Alexander Miethke, MD · Contact513-636-5581Alexander.Miethke@cchmc.org
- Alexander Miethke, MD · Principal investigator
Recruiting
Study team
Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID CIN001-MRI biomarkers in AILD
Principal investigator
Alexander Miethke, MD
Cincinnati Childrens Hospital Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.