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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03178630
Other study ID # CIN002 MRI biomarkers in AILD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 20, 2017
Est. completion date February 2031

Study information

Verified date February 2023
Source Children's Hospital Medical Center, Cincinnati
Contact Alexander Miethke, MD
Phone 513-636-8948
Email alexander.miethke@cchmc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date February 2031
Est. primary completion date February 2030
Accepts healthy volunteers No
Gender All
Age group 6 Years to 23 Years
Eligibility Inclusion Criteria: 1. Age 6-23 years old. 2. Established clinical diagnosis of AIH or PSC. Exclusion Criteria: 1. History of liver transplantation. 2. Chronic Hepatitis B or untreated hepatitis C virus infection. 3. Pregnancy. 4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia). 5. Diagnosis of cystic fibrosis or biliary atresia 6. Diagnosis of cardiac hepatopathy. 7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease. 8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).

Study Design


Locations

Country Name City State
United States Cincinnati Children's Hospital and Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 24 months
Primary 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). 24 months
Primary 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). 24 months
Primary 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. 120 months
Primary long-term clinical outcomes: hospital admissions for cholangitis 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. 120 months
Primary long-term clinical outcomes:endoscopic interventions for biliary strictures 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. 120 months
Primary long-term clinical outcomes:diagnosis of cholangiocarcinoma 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. 120 months
Primary long-term clinical outcomes: variceal bleeding 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. 120 months
Primary long-term clinical outcomes: ascites 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. 120 months
Secondary 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). 24 months
Secondary 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. 24 months
Secondary 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. 120 months
Secondary 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. 120 months
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