Actively Recruiting
MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2024-12-12
150
Participants Needed
1
Research Sites
727 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factor for chronic liver disease among adolescents. This is a longitudinal study to identify surrogate endpoints with an accurate predictive value for the progression of hepatobiliary damage in subjects with pediatric onset AILD. This study will involve collection of MRI-based data at the time of enrollment and at year 1 and 2 of follow up, and collection of clinical data for 10 years following enrollment. There is a strong possibility that MRI quantitative techniques may be more sensitive to disease progression than standard clinical and laboratory tests. To investigate predictivity of MRI based biomarkers, summary measures of MRCP/MREL from baseline, Year 1 and Year 2, e.g. change rate, maximum, and average will be calculated as predictors for Year 10 clinical outcomes. The same predictors will also be used to model native liver survival in a proportional hazard regression. Findings from this study may be used to assess disease progression and to predict complications and survival of liver disease patients.
CONDITIONS
Official Title
MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 23 years old
- Established clinical diagnosis of autoimmune hepatitis or primary sclerosing cholangitis
You will not qualify if you...
- History of liver transplantation
- Chronic Hepatitis B or untreated hepatitis C virus infection
- Pregnancy
- Absolute contraindications to 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 may worsen with MREL, like Epidermolysis bullosa
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
A
Alexander Miethke, MD
CONTACT
C
Cyd Castro Rojas, PhD
CONTACT
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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