Quantitative Ultrasound With Liver Incytes for Evaluation of Non-Alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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The purpose of this study is to prospectively evaluate the utility of Liver Incytes in assessing NAFLD with or without advanced fibrosis in patients seen in liver clinics for suspected NAFLD diagnosis.

Detailed Description
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The proposed study will evaluate the performance characteristics of LSM as a measure of fibrosis and ACE as a measure of hepatic steatosis by Liver Incytes in patients with different stages of NAFLD. In addition, the diagnostic accuracy of ACE will be compared to CAP and LSM as measured by Liver Incytes to that measured by FibroScan® using liver histology as the reference standard. The performance of these two methods will also be compared to that of non-invasive blood based markers such as APRI, FIB4, and NAFLD fibrosis score in predicting advanced fibrosis in biopsy proven NAFLD.

Official Title
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Quantitative Ultrasound With Liver Incytes for Evaluation of Non-Alcoholic Fatty Liver Disease

Conditions
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NAFLD, NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Diagnostic Test: Velacur by Sonic Incytes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 21 years or older Suspected NAFLD or NASH with plans to undergo standard of care liver biopsy History of biopsy proven NAFLD or NASH within 6 months prior to enrollment Planned liver biopsy for evaluation of NAFLD within 6 months of enrollment Ability to provide informed consent Exclusion Criteria: Fasting for less than three hours prior to the scan Subject is a pregnant or lactating female Subject with current, significant alcohol consumption or history of significant alcohol consumption for a period of more than 3 consecutive months any time within 1 year prior to screening. Significant alcohol consumption is defined as more than 20 gram per day in females and more than 30 grams per day in males, on average (a standard drink in the US is considered to be 14 grams of alcohol). Subject is unable to reliably quantify alcohol consumption based upon local study physician judgment. Subject uses drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks in the year prior to screening Subject with history of cirrhosis or clinical evidence of hepatic decompensation as defined by the presence of any of the following abnormalities at screening Serum albumin less than 3.5 grams/deciliter (g/dL). INR greater than 1.5. Direct bilirubin greater than 1.3 milligrams per deciliter (mg/dL). Subject has a history of bleeding esophageal varices, ascites or hepatic encephalopathy Subject has history of other forms of chronic liver diseases such as viral hepatitis, autoimmune hepatitis, cholestatic liver disease (primary biliary cirrhosis or primary sclerosing cholangitis). Subject with active substance abuse Acute hepatitis defined as AST/ALT > 500 U/L Patients with a pacemaker or defibrillator Ascites

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will undergo quantitative ultrasound with Liver Incytes by a certified technician.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Velacur by Sonic Incytes<br>Patients with known or suspected Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH) will be scanned with Velacur for assessment of liver fibrosis. | Diagnostic Test: Velacur by Sonic Incytes<br>* liver stiffness measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Stiffness Measured by Velacur | Assessing correlation of liver stiffness measurements (LSM) as measured by Velacur to grade of fibrosis on liver histology of patients with NAFLD who underwent standard of care liver biopsy. Results are reported per fibrosis category: F0, F1, F2, F3, and F4. | one day | 
| Liver Stiffness Measured by Transient Elastography | Assessing correlation of liver stiffness measurements (LSM) as measured by FibroScan to grade of fibrosis on liver histology of patients with NAFLD who underwent standard of care liver biopsy. Results are reported per fibrosis category: F0, F1, F2, F3, and F4. | one day |