Methods to Detect Liver Fibrosis

Stopped early · Not applicable

Conditions studied: Liver Fibroses, Hepatic Steatosis

In brief

The goal of this study is to learn more about liver fibrosis and methods to detect it. We will evaluate and compare multiple MRI based measures of liver fibrosis in subjects with and without liver disease.

Key facts

Study ID

NCT03027700

Run by

Children's Hospital Medical Center, Cincinnati

People needed

6

Starts

2017-01-26

Expected to finish

2018-12-30

Last updated by the study team

2020-01-29

Who can join

Age: 8 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Group 1:
• Healthy subjects with no known or suspected liver disease
• Age 8 - 21 years
• Groups 2 and 3:
• Biopsy confirmed liver fibrosis (F1/F2 Group 2, F3/F4 Group 3)
• Age 8 - 21 years
• Group 4:
• Biopsy confirmed hepatic steatosis AND biopsy confirmed liver fibrosis (any stage)
• Age 8 - 21 years

You may not qualify if…

• All subjects:
• Subjects <8 years of age and >21 years of age.
• BMI > 35 kg/m2
• Subjects deemed to possibly require sedation to undergo MR imaging
• Inability to lie still for 90 minutes
• Routine exclusions to MRI - e.g., implanted hardware
• Pregnancy (verbal pregnancy screens - per standard practice in Radiology - will be administered to all female participants of child-bearing age at the time of enrollment and again immediately prior to imaging)
• Prior history of liver transplantation
• Group 1
• ALT ≥30 U/L
• Clinical history or lab/biopsy results suggestive of the presence of liver disease including: steatosis, fibrosis, inflammation, tumor, etc.
• Group 2 and 3
• Diagnosis of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis
• Biopsy >6 months prior to research MRI examination
• Initiation of any medications (e.g. steroids, immunosuppressants, antivirals) or procedures (e.g. Kasai portoenterostomy) to treat the liver disease during the time between liver biopsy and study visit
• Group 4
• Biopsy >6 months prior to research MRI examination
• Hepatic fat fraction >5%
• Substantial weight loss (>10% of weight at time of biopsy) during the time between biopsy and study visit
• Initiation of any medications to treat NAFLD (e.g. vitamin E) during the time between biopsy and study visit

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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