NCT03175471 MRI Based Biomarkers in Pediatric Autoimmune Liver Disease
| NCT ID | NCT03175471 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Autoimmune Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 115 participants |
| Start Date | 2017-01-17 |
| Primary Completion | 2030-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 115 participants in total. It began in 2017-01-17 with a primary completion date of 2030-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 6-23 years old. 2. Established or suspected clinical diagnosis of AIH or PSC. Exclusion Criteria: 1. History of liver transplantation. 2. Chronic Hepatitis B or untreated hepatitis C virus infection. 3. Pregnancy. 4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia). 5. Diagnosis of cystic fibrosis or biliary atresia 6. Diagnosis of cardiac hepatopathy. 7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease. 8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).
Contact & Investigator
Alexander Miethke, MD
PRINCIPAL INVESTIGATOR
Cincinnati Childrens Hospital Medical Center
Frequently Asked Questions
Who can join the NCT03175471 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 23 Years, studying Autoimmune Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03175471 currently recruiting?
Yes, NCT03175471 is actively recruiting participants. Contact the research team at Alexander.Miethke@cchmc.org for enrollment information.
Where is the NCT03175471 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT03175471 clinical trial?
NCT03175471 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Alexander Miethke, MD at Cincinnati Childrens Hospital Medical Center. The trial plans to enroll 115 participants.