MRI Biomarkers in Pediatric Autoimmune Liver Disease
This study is looking at how well special MRI scans, called MR cholangiopancreatography (MRCP) and MR elastography (MREL), can help doctors understand autoimmune liver diseases (AILD) in children and young adults. AILD includes conditions like Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH), where the body's immune system mistakenly attacks the liver. Researchers want to see if these MRI scans can accurately show bile duct damage and liver scarring (fibrosis) without needing more invasive procedures. You might be able to join if you are between 6 and 23 years old and have a diagnosis or suspected diagnosis of AIH or PSC. The study will measure the success of these MRI methods by comparing them to liver tissue assessments after 36 months. The current recruitment status is unclear.
- Study design
- This is an observational study aiming to enroll 115 participants. It is not testing a new treatment but rather observing how existing MRI techniques can be used.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes, including MRI results and liver tissue assessments, will be measured at 36 months.
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MRI Based Biomarkers 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
- MRI based outcomes36 months
MRCP based assessment of intrahepatic and extrahepatic duct irregularities by Majoie classification (on 4 and 5 point scale of 0-3 and 0-4 respectively; 0: No visible abnormalities, 1: minimal dilatation/irregularities, 2: saccular dilatations/segmental stricture, 3: severe pruning, 4: Extremely irregular margin). MREL based quantification of mean shear stiffness (kPa) of liver.
- Liver histopathology based assessment of bile duct injury by ISHAK Score36 months
Assessment of bile duct injury by ISHAK Score (Confluent necrosis: on the 7 point scale of 0-6; Focal necrosis on the 4 point scale of 0-4 and portal inflammation on the 4 point scale of 0-4).
- Liver histopathology based assessment of bile duct injury by Ludwig score36 months
Assessment of bile duct injury by Ludwig score (on five point scale of 0-4; 0: No ductal injury, 1: portal inflammation, 2: periportal inflammation, 3: Portal bridging, 4: Nodular cirrhosis).
- Liver histopathology based assessment of liver fibrosis by Nakanuma score36 months
Assessment of liver fibrosis by Nakanuma score for on the 4 point scale of 0-3 (0; No portal fibrosis, 1; Portal fibrosis; 2; Bridging fibrosis, 3; Liver cirrhosis) .
- Liver histopathology based assessment of liver fibrosis by Ishak score36 months
Assessment of liver fibrosis by Ishak score on the 7 point scale of 0-6 (0; Absent, 1; confluent necrosis, 2; necrosis in some areas, 3; necrosis in most areas, 4; necrosis with occasional portal-central bridging necrosis, 5; necrosis with multiple portal-central bridging necrosis, 6; Panacinar or multiacinar necrosis).
- Liver histopathology based assessment of cholangitis and hepatic activity36 months
Cholangitis and hepatic activity by Nakanuma score for on the 4 point scale of 0-3 (0; No bile duct loss, 1; Bile duct loss in \<1/3 of portal tracts; 2; Bile duct loss in 1/3-2/3 of portal tracts, 3; Bile duct loss in \>2/3 of portal tracts).
- Serum based outcome36 months
Quantification of serum alkaline phosphatase (ALP in U/L) and Gamma-glutamyl transpeptidase (GGT in U/L).
- Enhanced Liver Fibrosis (ELF) score36 months
Assesment of Enhanced Liver Fibrosis (ELF) score on continuous scale of 1-10; \<7.7 none -mild. ≥7.7 -\<9.8 moderate, \>9.8 sever).