MRI Based Biomarkers in Pediatric Autoimmune Liver Disease

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT03175471
Status
Recruiting
Apply to this trial

Conditions

  • Autoimmune Hepatitis
  • Autoimmune Liver Disease
  • Primary Sclerosing Cholangitis

Eligibility Criteria

Sex
ALL
Age
6 Years - 23 Years
Healthy Volunteers
Not accepted

Study Details

Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factors for chronic liver disease among adolescents. In all these conditions, autoimmune lymphocyte responses are thought to orchestrate inflammatory injury against hepatocytes (primarily in AIH) or cholangiocytes (in PSC). In this proposal we aim to evaluate the Magnetic Resonance Imaging (MRI) modalities; MR cholangiopancreatography (MRCP) and MR elastography (MREL), as non-invasive biomarkers to assess two primary pathophysiological processes of AILD: bile duct damage and liver fibrosis. In this cross-sectional study MRI based findings of bile duct injury and liver fibrosis will be correlated with both liver histology and circulating biomarkers of these disease processes.

Key Dates

Start date
Jan 17, 2017
Status verified
Dec 2024
Primary completion
Jan 30, 2026
Completion
Jan 30, 2027

Study Design

Enrollment
115 participants (estimated)

Arms

  • Arm: Patients with autoimmune liver disease
    Patients (6-23 y.o.) with established clinical diagnosis of AIH or suspected diagnosis of AIH based on elevated serum AST or ALT, elevated IgG level \>1.1 ULN, elevated titer of autoantibodies, including ANA, SMA, LKM, LC-1 or SLA, which is consistent with the simplified criteria for the diagnosis of AIH in children will be enrolled. Patients (6-23 y.o.) with established clinical diagnosis of PSC or Suspected diagnosis of PSC supported by abnormal cholangiogram (ERCP or MRCP) or elevated GGT\>1.5 ULN and dilated bile ducts by liver ultrasound will be enrolled.

Primary Outcome Measure

MRI based outcomes [ Time Frame: 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Childrens Hospital Medical CenterCincinnatiOhio45229
Alexander Miethke, MD
[email protected]
513-636-5581
Alexander Miethke, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cincinnati, OH

By research site
Cincinnati Childrens Hospital Medical Center· Cincinnati, OH

Related Studies