Actively Recruiting

Age: 6Years - 23Years
All Genders
ID03175471

MRI Based Biomarkers for Bile Duct Injury and Liver Fibrosis in Pediatric Autoimmune Liver Disease

Led by Children's Hospital Medical Center, Cincinnati · Updated on 2024-12-12

115

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying autoimmune liver diseases (AILD), including Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH), which commonly cause chronic liver disease in adolescents. These diseases involve immune system attacks on liver cells or bile ducts, causing inflammation and damage. The study aims to evaluate non-invasive MRI techniques, specifically MR cholangiopancreatography (MRCP) and MR elastography (MREL), as biomarkers to assess bile duct damage and liver fibrosis in these conditions. Participants include children and young adults aged 6 to 23 years with either confirmed or suspected diagnoses of AIH or PSC based on clinical and laboratory criteria. The study is cross-sectional and involves MRI scans to detect bile duct injury and liver fibrosis. MRI findings will be compared with liver biopsy results and blood tests that reflect disease activity. This approach helps understand how well MRI can serve as a non-invasive tool for disease assessment. During the study, participants will undergo MRI imaging along with blood tests and liver histology evaluations. Researchers will measure liver fibrosis and bile duct injury using established scoring systems from biopsy samples and compare these with MRI and blood markers. The study will track various MRI and serum outcomes over 36 months to assess the relationship between imaging results and disease severity. This ongoing research aims to improve non-invasive monitoring of pediatric autoimmune liver diseases.

CONDITIONS

Brief Title

MRI Based Biomarkers in Pediatric Autoimmune Liver Disease

Who Can Participate

Age: 6Years - 23Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6 to 23 years old
  • Established or suspected clinical diagnosis of autoimmune hepatitis (AIH) or primary sclerosing cholangitis (PSC)
Not Eligible

You will not qualify if you...

  • History of liver transplantation
  • Chronic Hepatitis B or untreated hepatitis C virus infection
  • Pregnancy
  • Absolute contraindication for MRI such as pacemaker, metallic implants, or 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 that could be worsened by MR elastography, such as Epidermolysis bullosa

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 36 months

Participants undergo MRI and liver assessments to evaluate bile duct injury and liver fibrosis.

Periodic imaging and serum assessments during the study period

Long-term Monitoring

Duration - Up to 36 months

Participants are monitored over time to observe changes in liver condition using MRI-based biomarkers and serum outcomes.

Ongoing follow-up visits over the 36-month study period

Trial Site Locations

Total: 1 location

1

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

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Research Team

A

Alexander Miethke, MD

C

Cyd Castro Rojas, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Longitudinal changes in quantitative magnetic resonance imaging metrics in children and young adults with autoimmune liver disease.

Neeraja Mahalingam, Andrew T Trout, Bin Zhang...

https://pubmed.ncbi.nlm.nih.gov/36799997

Associations Between Quantitative MRI Metrics and Clinical Risk Scores in Children and Young Adults With Autoimmune Liver Disease.

Joseph McCrary, Andrew T Trout, Neeraja Mahalingam...

https://pubmed.ncbi.nlm.nih.gov/35080454

Association Between MR Elastography Liver Stiffness and Histologic Liver Fibrosis in Children and Young Adults With Autoimmune Liver Disease.

Jonathan R Dillman, Andrew T Trout, Amy E Taylor...

https://pubmed.ncbi.nlm.nih.gov/38630086