Using MRI to predict outcomes in children with autoimmune liver disease
Official title: Longitudinal Study for the Assessment of MRI Based Biomarkers as a Predictors of Clinical Endpoints in Pediatric Onset Autoimmune Liver Disease
Run by Children's Hospital Medical Center, Cincinnati · NCT03178630 · Data updated 2026-11-12
This study is testing if MRI scans can help predict how well children with autoimmune liver diseases will do over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years to 23 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | February 20, 2017 |
| Main results expected | February 2030 |
| Study ends | February 2031 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT03178630 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children and adolescents aged 6 to 23 with a confirmed diagnosis of autoimmune liver disease.
✕Probably not a fit
Patients with a history of liver transplantation or those with certain contraindications for MRI will 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 identify MRI biomarkers that can predict clinical outcomes in pediatric patients with autoimmune liver diseases, including Autoimmune Hepatitis and Primary Sclerosing Cholangitis. Participants aged 6 to 23 will undergo MRI scans at enrollment and again at one and two years, with clinical data collected over a ten-year period. The study will analyze changes in MRI data to determine their predictive value for liver disease progression and survival. By focusing on MRI-based metrics, the study seeks to improve the sensitivity of disease monitoring compared to traditional clinical tests.
Why it matters
Potential benefit: If successful, this study could lead to more accurate monitoring and management of liver disease progression in children, potentially improving patient outcomes.
How similar studies have gone: While the use of MRI in liver disease monitoring is established, this specific approach focusing on pediatric autoimmune liver disease is 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 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 Children's Hospital and 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using Siplizumab to prevent immune issues in liver transplant patients with autoimmune liver disease
This study is testing if a new medication called siplizumab can help prevent immune problems in adults with autoimmune liver disease who are getting a liver transplant.
-
Using MRI to assess liver damage in children with 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.
-
Identifying liver disease-specific gut microbiomes
This study is trying to find out if certain gut bacteria are linked to chronic liver diseases in adults, including autoimmune hepatitis and primary biliary cholangitis, by analyzing blood and stool samples from patients and their household members.
-
Predicting liver injury in autoimmune hepatitis using a specific antibody test
This study is testing if a specific antibody test can help doctors better diagnose autoimmune hepatitis in both adults and children, especially when other tests don't show clear results.
-
Improving outcomes in pediatric autoimmune liver disease
This study is trying to improve care for kids with autoimmune liver diseases by collecting and sharing information about their treatments and health to help doctors provide better support.
-
Inebilizumab for Autoimmune Hepatitis: a study in adults
This trial tests whether inebilizumab can be safely used in adults with autoimmune hepatitis and whether it helps reduce liver disease activity and the need for steroids.
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.