MRI Based Biomarkers in Pediatric Autoimmune Liver Disease
Observational · No treatment assigned · 1 site · Children's Hospital Medical Center, Cincinnati
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Autoimmune Liver Disease, Primary Sclerosing Cholangitis and Autoimmune Hepatitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 6 to 23
- Any sex
Some of the main requirements, copied from the record:
- Age 6-23 years old.
- Established or suspected clinical diagnosis of AIH or PSC.
There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 115 participants are expected to take part.
- The study has 1 group.
- Start date: 2017-01-17.
- Main results expected around 2030-01-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- Patients with autoimmune liver disease
Main thing being measured
- MRI based outcomes (36 months)
- Liver histopathology based assessment of bile duct injury by ISHAK Score (36 months)
- Liver histopathology based assessment of bile duct injury by Ludwig score (36 months)
In the researchers’ words
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…
Words you might see
- MRCP: an MRI scan of the bile ducts and pancreas.
- Biopsy / histology: a small tissue sample examined under a microscope.
- Liver stiffness (elastography): a scan that estimates liver scarring.
- Autoimmune hepatitis: a liver disease where the immune system attacks the liver.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Autoimmune Liver Disease; Primary Sclerosing Cholangitis; Autoimmune Hepatitis |
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
| Enrollment | 115 (estimated) |
| Start date | 2017-01-17 |
| Primary completion (est.) | 2030-01-30 |
| First posted | 2017-06-05 |
| Last updated | 2026-08-19 |
| Official title | Cross-sectional Study for Assessment of MRI Based Biomarkers of Bile Duct Injury and Hepatic Fibrosis in Pediatric Onset Autoimmune Liver Disease |
| ClinicalTrials.gov ID | NCT03175471 |
Interventions
- None listed
Full eligibility criteria (from the record)
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).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Childrens Hospital Medical Center | Cincinnati, Ohio | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.