Using MRI to assess liver damage in children with autoimmune liver disease
Official title: Cross-sectional Study for Assessment of MRI Based Biomarkers of Bile Duct Injury and Hepatic Fibrosis in Pediatric Onset Autoimmune Liver Disease
Run by Children's Hospital Medical Center, Cincinnati · NCT03175471 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 6 Years to 23 Years |
| Sex | All |
| Enrollment | 115 (estimated) |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | January 17, 2017 |
| Main results expected | January 30, 2030 |
| Study ends | January 30, 2030 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT03175471 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with a history of liver transplantation, chronic hepatitis infections, or other specified liver diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: Alexander.Miethke@cchmc.org
- Phone: 513-636-8948
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.