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Recruiting NCT03178630

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

— Observational Autoimmune Liver Disease Autoimmune Hepatitis Primary Sclerosing Cholangitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Autoimmune Liver Disease, Autoimmune Hepatitis, Primary Sclerosing Cholangitis. Basic parameters: 6 years — 23 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Change of intrahepatic bile duct irregularities between V0 (baseline visit) and V1 (visit after12 months) or V2 (visit after 24 months). [Time frame: 24 months]
  • Change of extra-hepatic duct irregularities between V0 (baseline visit) and V1 (visit after 12 months) or V2 (visit after 24 months). [Time frame: 24 months]
  • Mean shear stiffness of the liver [Time frame: 24 months]
  • long-term clinical outcomes: survival with the native liver [Time frame: 120 months]
  • long-term clinical outcomes: hospital admissions for cholangitis [Time frame: 120 months]
  • long-term clinical outcomes:endoscopic interventions for biliary strictures [Time frame: 120 months]
  • long-term clinical outcomes:diagnosis of cholangiocarcinoma [Time frame: 120 months]
  • long-term clinical outcomes: variceal bleeding [Time frame: 120 months]
  • long-term clinical outcomes: ascites [Time frame: 120 months]
Secondary outcome measures (4)
  • Changes in liver/spleen volumes [Time frame: 24 months]
  • Changes in T1rho, T1 and T2 mapping [Time frame: 24 months]
  • Clinical endpoints of AILD: Pruritus [Time frame: 120 months]
  • Clinical endpoints of AILD [Time frame: 120 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Cincinnati Children's Hospital and Medical Center — Cincinnati

Publications

  • Farr R, Rojas CC, Alquraish M, Hommel K, Sahay R, Weymann A, Saarela K, Kulkarni S, Ayers M, Squires J, Taylor A, Kalkwarf HJ, Miethke A. Longitudinal, Multicenter Study of Clinical Factors Impacting Health-Related Quality of Life in Paediatric Autoimmune Liver Disease. Liver Int. 2026 Apr;46(4):e70581. doi: 10.1111/liv.70581. PMID 41804276

Identifiers

NCT: NCT03178630 · CIN002 MRI biomarkers in AILD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗