MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease

Recruiting now

Conditions studied: Autoimmune Liver Disease, Autoimmune Hepatitis, Primary Sclerosing Cholangitis

In brief

Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factor for chronic liver disease among adolescents. This is a longitudinal study to identify surrogate endpoints with an accurate predictive value for the progression of hepatobiliary damage in subjects with pediatric onset AILD. This study will involve collection of MRI-based data at the time of enrollment and at year 1 and 2 of follow up, and collection of clinical data for 10 years following enrollment. There is a strong possibility that MRI quantitative techniques may be more sensitive to disease progression than standard clinical and laboratory tests. To investigate predictivity of MRI based biomarkers, summary measures of MRCP/MREL from baseline, Year 1 and Year 2, e.g. change rate, maximum, and average will be calculated as predictors for Year 10 clinical outcomes. The same predictors will also be used to model native liver survival in a proportional hazard regression. Findings from this study may be used to assess disease progression and to predict complications and survival of liver disease patients.

Key facts

Study ID

NCT03178630

Run by

Children's Hospital Medical Center, Cincinnati

People needed

150

Starts

2017-02-20

Expected to finish

2031-02-01

Last updated by the study team

2024-12-12

Who can join

Age: 6 and older, up to 23. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 6-23 years old.
• Established clinical diagnosis of AIH or PSC.

You may not qualify 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).

Where it is running

• Cincinnati Children's Hospital and Medical Center — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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