MRI Biomarkers in as Predictor of Clinical Endpoints 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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 6-23 years old.
Established 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 150 patients between 6 and 23 years of age with a diagnosis of PSC or AIH will be enrolled and followed up to 10 Years.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Patients with autoimmune liver disease
Trial outcomes
Primary outcomes
1
Change of intrahepatic bile duct irregularities between V0 (baseline visit) and V1 (visit after12 months) or V2 (visit after 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).
Time frame
24 months2
Change of extra-hepatic duct irregularities between V0 (baseline visit) and V1 (visit after 12 months) or V2 (visit after 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).
Time frame
24 months3
Mean shear stiffness of the liver
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).
Time frame
24 months4
long-term clinical outcomes: survival with the native liver
Annual assessment of survival with the native liver (Yes=1, No=0) will be done within 10 years of follow-up.
Time frame
120 monthsSecondary outcomes
1
Changes in liver/spleen volumes
Changes in liver/spleen volumes (mL) between V0 (baseline visit) and V1 (visit after 12 months) or V2 (visit after 24 months).
Time frame
24 months2
Changes in T1rho, T1 and T2 mapping
Readouts of T1rho, T1 and T2 mapping between baseline MRI at V0 (baseline visit) and repeat ones at V1 (after12 months) or V2 (after 24 months) in msec.
Time frame
24 months3
Clinical endpoints of AILD: Pruritus
Annual assessment for Pruritus (on visual analogue scale of 0-10) will be done within 10 years of follow-up.
Time frame
120 months4
Clinical endpoints of AILD
Annual assessment for Clinical diagnosis of hepatopulmonary syndrome (Yes=1, No=0) and/or hepatic encephalopathy (Yes=1, No=0) will be done within 10 years of follow-up.
Time frame
120 monthsSponsors and contacts
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Source ClinicalTrials.gov