RECRUITING

MRI Based Biomarkers in Pediatric Autoimmune Liver Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Cross-sectional Study for Assessment of MRI Based Biomarkers of Bile Duct Injury and Hepatic Fibrosis in Pediatric Onset Autoimmune Liver Disease

Quick Facts

Study Start:2017-01-17
Study Completion:2027-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03175471

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 23 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 6-23 years old.
  2. 2. Established or suspected clinical diagnosis of AIH or PSC.
  1. 1. History of liver transplantation.
  2. 2. Chronic Hepatitis B or untreated hepatitis C virus infection.
  3. 3. Pregnancy.
  4. 4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).
  5. 5. Diagnosis of cystic fibrosis or biliary atresia
  6. 6. Diagnosis of cardiac hepatopathy.
  7. 7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease.
  8. 8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).

Contacts and Locations

Study Contact

Alexander Miethke, MD
CONTACT
513-636-8948
Alexander.Miethke@cchmc.org
Cyd Castro Rojas, PhD
CONTACT
513-517-0580
Cyd.CastroRojas@cchmc.org

Principal Investigator

Alexander Miethke, MD
PRINCIPAL_INVESTIGATOR
Cincinnati Childrens Hospital Medical Center

Study Locations (Sites)

Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Alexander Miethke, MD, PRINCIPAL_INVESTIGATOR, Cincinnati Childrens Hospital Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-01-17
Study Completion Date2027-01-30

Study Record Updates

Study Start Date2017-01-17
Study Completion Date2027-01-30

Terms related to this study

Additional Relevant MeSH Terms

  • Autoimmune Liver Disease
  • Primary Sclerosing Cholangitis
  • Autoimmune Hepatitis