Using MRI to assess liver damage in children with autoimmune liver disease

Cross-sectional Study for Assessment of MRI Based Biomarkers of Bile Duct Injury and Hepatic Fibrosis in Pediatric Onset Autoimmune Liver Disease

This study is testing if MRI scans can safely show liver damage in children with autoimmune liver diseases like PSC and AIH, helping doctors understand their condition better without needing invasive tests.

Quick facts

• Study type: Observational
• Enrollment: 115 (estimated)
• Ages: 6 Years to 23 Years
• Sex: All
• Sponsor: Children's Hospital Medical Center, Cincinnati (Academic / other)
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT03175471 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the use of Magnetic Resonance Imaging (MRI) techniques, specifically MR cholangiopancreatography (MRCP) and MR elastography (MREL), as non-invasive biomarkers for assessing bile duct damage and liver fibrosis in pediatric patients with autoimmune liver diseases, including Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH). The study will correlate MRI findings with liver histology and circulating biomarkers to better understand the pathophysiological processes involved in these conditions. By focusing on children aged 6-23 years, the study seeks to provide insights into the progression of these diseases without the need for invasive procedures.

Who should consider this trial

Good fit: Ideal candidates for this study are children and adolescents aged 6-23 years with an established or suspected diagnosis of Autoimmune Hepatitis or Primary Sclerosing Cholangitis.

Not a fit: Patients with a history of liver transplantation, chronic hepatitis infections, or other specified liver diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved non-invasive diagnostic methods for monitoring liver damage in children with autoimmune liver diseases.

How similar studies have performed: While the use of MRI in liver assessment is established, this specific application in pediatric autoimmune liver disease is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age 6-23 years old.
2. Established or suspected clinical diagnosis of AIH or PSC.

Exclusion Criteria:

1. History of liver transplantation.
2. Chronic Hepatitis B or untreated hepatitis C virus infection.
3. Pregnancy.
4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).
5. Diagnosis of cystic fibrosis or biliary atresia
6. Diagnosis of cardiac hepatopathy.
7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease.
8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).

Where this trial is running

Cincinnati, Ohio

• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Alexander Miethke, MD — Cincinnati Childrens Hospital Medical Center
• Study coordinator: Alexander Miethke, MD

Conditions Autoimmune Liver Disease; Primary Sclerosing Cholangitis; Autoimmune Hepatitis