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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03175471
Other study ID # CIN001-MRI biomarkers in AILD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 17, 2017
Est. completion date January 30, 2027

Study information

Verified date March 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 115
Est. completion date January 30, 2027
Est. primary completion date January 30, 2026
Accepts healthy volunteers No
Gender All
Age group 6 Years to 23 Years
Eligibility Inclusion Criteria: 1. Age 6-23 years old. 2. Established or suspected 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 Childrens Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mahalingam N, Trout AT, Zhang B, Castro-Rojas C, Miethke AG, Dillman JR. Longitudinal changes in quantitative magnetic resonance imaging metrics in children and young adults with autoimmune liver disease. Abdom Radiol (NY). 2023 Feb 17. doi: 10.1007/s00261-022-03733-9. Online ahead of print. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
36 months
Primary 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). 36 months
Primary 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). 36 months
Primary 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) . 36 months
Primary Liver histopathology based assessment of liver fibrosis by Ishak score 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). 36 months
Primary Liver histopathology based assessment of cholangitis and hepatic activity 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). 36 months
Primary Serum based outcome Quantification of serum alkaline phosphatase (ALP in U/L) and Gamma-glutamyl transpeptidase (GGT in U/L). 36 months
Primary Enhanced Liver Fibrosis (ELF) score 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). 36 months
Secondary MR T1rho, T1, T2 Imaging Mean of MR T1rho, T1, T2 signal in msec to measure the inflammation. 36 Months
Secondary Liver Morphometry Collagen deposition in percent area fibrosis by image analysis 36 Months
Secondary 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). 36 Months
Secondary Serum based outcomes Quantification of serum fractionated ALP (U/L) 36 Months
Secondary Serum MMP7 Quantification of serum MMP7 (pg/mL) 36 Months
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