Using MRI to predict outcomes in children with autoimmune liver disease

Longitudinal Study for the Assessment of MRI Based Biomarkers as a Predictors of Clinical Endpoints in Pediatric Onset Autoimmune Liver Disease

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
• Enrollment: 150 (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: NCT03178630 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 6 to 23 with a confirmed diagnosis of autoimmune liver disease.

Not a fit: Patients with a history of liver transplantation or those with certain contraindications for MRI will not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Cincinnati, Ohio

• 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

Conditions Autoimmune Liver Disease; Autoimmune Hepatitis; Primary Sclerosing Cholangitis