MRI Biomarkers in Pediatric Autoimmune Liver Disease
This observational study is looking at how MRI scans can help predict the progression of autoimmune liver diseases (AILD) in children and young adults. AILD includes conditions like Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH). Researchers want to see if MRI techniques are better at showing disease changes than standard tests. You might be able to join if you are between 6 and 23 years old and have a diagnosis of AIH or PSC. The study will measure changes in your bile ducts and liver stiffness using MRI over 24 months to see if these measurements can predict how the disease progresses.
- Study design
- This is an observational study planning to enroll 150 participants. It is not a treatment study, but rather aims to understand disease progression.
- What's involved
- You would have MRI scans at the start of the study, and again after 1 and 2 years. Clinical data will be collected for 10 years after you join.
- Compensation
- Not stated in the trial record.
- Follow-up
- Clinical data will be collected for 10 years following enrollment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Alexander Miethke, MD · PRINCIPAL_INVESTIGATOR · Cincinnati Childrens Hospital Medical Center
Who to contact
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What this trial measures
- Change of intrahepatic bile duct irregularities between V0 (baseline visit) and V1 (visit after12 months) or V2 (visit after 24 months).24 months
Change of intrahepatic bile duct irregularities between V0 and V1 or V2 by MRCP (scored by Majoie classification on 4 point scale of 0-3).
- Change of extra-hepatic duct irregularities between V0 (baseline visit) and V1 (visit after 12 months) or V2 (visit after 24 months).24 months
Change of extra-hepatic duct irregularities between V0 and V1 or V2 by MRCP (scored by Majoie classification on 5 point scale 0-4).
- Mean shear stiffness of the liver24 months
Change in mean shear stiffness (kPa) of the liver by MREL between V0 (baseline visit) and V1 ( visit after 12 months) or V2 (visit after 24 months).
- long-term clinical outcomes: survival with the native liver120 months
Annual assessment of survival with the native liver (Yes=1, No=0) will be done within 10 years of follow-up.
- long-term clinical outcomes: hospital admissions for cholangitis120 months
Annual assessment of long-term clinical outcomes will be done within 10 years of follow-up. Any hospital admissions for cholangitis (Yes=1, No=0) since last visit will be recorded at the time of follow-up.
- long-term clinical outcomes:endoscopic interventions for biliary strictures120 months
Annual assessment of long-term clinical outcomes will be done within 10 years of follow-up. Endoscopic interventions for biliary strictures (Yes=1, No=0) since last visit will be recorded at the time of follow-up.
- long-term clinical outcomes:diagnosis of cholangiocarcinoma120 months
Annual assessment of long-term clinical outcomes will be done within 10 years of follow-up. If there is diagnosis of cholangiocarcinoma (Yes=1, No=0) since last visit will be recorded.
- long-term clinical outcomes: variceal bleeding120 months
Annual assessment of long-term clinical outcomes will be done within 10 years of follow-up. Presence or absence of variceal bleeding (Yes=1, No=0) since last visit will be recorded.
- long-term clinical outcomes: ascites120 months
Annual assessment of long-term clinical outcomes will be done within 10 years of follow-up. Presence or absence of ascites (Yes=1, No=0) since last visit will be recorded.