MRI Based Biomarkers in Pediatric Autoimmune Liver Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-23
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 6-23 years old.
Established or suspected clinical diagnosis of AIH or PSC.
Disqualifiers
History of liver transplantation.
Chronic Hepatitis B or untreated hepatitis C virus infection.
Pregnancy.
Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).
Trial population
A total of 115 patients between 6 and 23 years of age with a diagnosis of PSC or AIH will be enrolled.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
115 Participants
are grouped into 1 trial groupGroup A: Patients with autoimmune liver disease
Trial outcomes
Primary outcomes
1
MRI based outcomes
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.
Time frame
36 months2
Liver histopathology based assessment of bile duct injury by ISHAK Score
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).
Time frame
36 months3
Liver histopathology based assessment of bile duct injury by Ludwig score
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).
Time frame
36 months4
Liver histopathology based assessment of liver fibrosis by Nakanuma score
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) .
Time frame
36 monthsSecondary outcomes
1
MR T1rho, T1, T2 Imaging
Mean of MR T1rho, T1, T2 signal in msec to measure the inflammation.
Time frame
36 Months2
Liver Morphometry
Collagen deposition in percent area fibrosis by image analysis
Time frame
36 Months3
Liver histopathology based outcomes
Liver histopathology based grade of inflammation by Scheuer score on 5 point scale of 0-4; (0: No ductal injury, 1: portal inflammation, 2: periportal inflammation, 3: Portal to portal bridging, 4: Nodular cirrhosis).
Time frame
36 Months4
Serum based outcomes
Quantification of serum fractionated ALP (U/L)
Time frame
36 MonthsSponsors and contacts
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Source ClinicalTrials.gov