The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF

Completed · Not applicable

Conditions studied: Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH), Liver Fibroses, Liver Steatoses

In brief

The main purpose of this study is to compare the effectiveness of various non-invasive elastography techniques at determining liver stiffness measures in human subjects. Specifically, the investigators are comparing MRE and FibroScan to Vibroelastography (VE, Liver Incytes System). These techniques are used to measure stiffness in the liver.

Key facts

Study ID

NCT04682600

Run by

Sonic Incytes

People needed

164

Starts

2020-10-21

Expected to finish

2023-07-01

Last updated by the study team

2026-07-20

Who can join

Age: 19 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults, 19-75 years old
• Healthy volunteers or Patients with evidence of NAFLD such as one of the following:
• Previous liver biopsy consistent with NAFLD OR
• Evidence of hepatic steatosis on non-invasive assessment by one or more of the following criteria:
• Abdominal ultrasound within 12 months
• MRI-PDFF (greater than 12%) within 12 month
• FibroScan CAP score > 230 dB/m within 12 months OR At least 2 criteria for metabolic syndrome and increased stiffness on FibroScan (>8kPa) within 12 months
• Able to understand the informed consent form, study procedures and willing to participate in study
• If female and of child bearing potential, must agree to practice a highly effective contraception method.

You may not qualify if…

• Active viral hepatitis
• a. Patients with cured HCV (those with history of treatment and have Sustained Viral Response for 12 weeks (SVR12)) or controlled HBV with no viral detected for more than 6 months are eligible
• Decompensated cirrhosis (history of ascites, encephalopathy, or variceal bleeding)
• ALT or AST > 5 x ULN on historical blood work within the past 3 months
• BMI greater than 40 kg/m2 (or using cutoff based on MRI)
• Other known causes of chronic liver disease
• Individuals with history of persistent ethanol abuse (alcohol consumption > 20g etoh/day for women, > 40 g etoh/day for men)
• Individuals with surgically removed gallbladder
• Pregnant or planning to become pregnant while enrolled in this study
• Other conditions which would exclude patients from entering an MRI

Where it is running

• Beth Israel Deaconess Medical Centre — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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