Status:
UNKNOWN
The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF
Lead Sponsor:
Sonic Incytes
Conditions:
Non-Alcoholic Fatty Liver Disease (NAFLD)
Non-Alcoholic Steatohepatitis (NASH)
Eligibility:
All Genders
19-75 years
Phase:
NA
Brief Summary
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 investigator...
Detailed Description
The Liver Incytes system allows for full visualization of the liver with the low cost and portability of ultrasound. It is an adjustable multi-frequency technique, which can show large areas of the or...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04682600
Start Date
October 21 2020
End Date
July 1 2023
Last Update
December 9 2022
Active Locations (1)
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1
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, United States, 02215