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

• ClinicalTrials.gov Identifier: NCT04576923
• Recruitment Status: Active, not recruiting
• First Posted: October 6, 2020
• Last Update Posted: February 2, 2023
• Sponsor: Indiana University
• Collaborator: Sonic Incytes
• Information provided by (Responsible Party): Samer Gawrieh, Indiana University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
NAFLD; NASH - Nonalcoholic Steatohepatitis	Diagnostic Test: Liver Incytes	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All participants will undergo quantitative ultrasound with Liver Incytes by a certified technician.
• Masking: None (Open Label)
• Masking Description: This is an open label study in that all participants will receive the same study procedures.
• Primary Purpose: Diagnostic
• Official Title: Quantitative Ultrasound With Liver Incytes for Evaluation of Non-Alcoholic Fatty Liver Disease
• Actual Study Start Date: February 1, 2021
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Liver Incytes; Patients with known or suspected Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH) will be scanned with Liver Incytes.	Diagnostic Test: Liver Incytes; Ultrasound elasticity imaging

Outcome Measures

Primary Outcome Measures :

1. Correlation of Liver Incytes measurements to liver biopsy results. [ Time Frame: two years ]
   Assessing correlation of ACE and liver stiffness measurements (LSM) as measured by Liver Incytes to grade of steatosis and stage of fibrosis on liver histology of patients with NAFLD who undergo standard of care liver biopsy.
2. Correlation of Liver Incytes measurements to FibroScan® measurements for liver stiffness and liver steatosis. [ Time Frame: two years ]
   Comparing the performance of Liver Incytes to that of FibroScan® in the same patient population to determine if either test is more accurate in correlating with NAFLD histology.
3. Correlation of Liver Incytes measurements to non-invasive blood markers for predicting advanced fibrosis. [ Time Frame: two years ]
   Comparing the performance of Liver Incytes to that of non-invasive blood based markers such as APRI, FIB4, and NAFLD fibrosis score in predicting advanced fibrosis in biopsy proven NAFLD.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Adults aged 21 years or older
2. Suspected NAFLD or NASH with plans to undergo standard of care liver biopsy
3. History of biopsy proven NAFLD or NASH within 6 months prior to enrollment
4. Planned liver biopsy for evaluation of NAFLD within 6 months of enrollment
5. Ability to provide informed consent

Exclusion Criteria:

1. Fasting for less than three hours prior to the scan
2. Subject is a pregnant or lactating female
3. 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).
4. Subject is unable to reliably quantify alcohol consumption based upon local study physician judgment.
5. 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

6. Subject with history of cirrhosis or clinical evidence of hepatic decompensation as defined by the presence of any of the following abnormalities at screening

   1. Serum albumin less than 3.5 grams/deciliter (g/dL).
   2. INR greater than 1.5.
   3. Direct bilirubin greater than 1.3 milligrams per deciliter (mg/dL).
7. Subject has a history of bleeding esophageal varices, ascites or hepatic encephalopathy
8. 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).
9. Subject with active substance abuse
10. Acute hepatitis defined as AST/ALT > 500 U/L
11. Patients with a pacemaker or defibrillator
12. Ascites

Contacts and Locations

Locations

United States, Indiana

Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

Sonic Incytes

Investigators

• Principal Investigator: Samer Gawrieh, MD; Indiana University School of Medicine

More Information

• Responsible Party: Samer Gawrieh, Associate Professor of Clinical Medicine, Indiana University
• ClinicalTrials.gov Identifier: NCT04576923
• Other Study ID Numbers: Liver Incytes for NAFLD; 2009698457 ( Other Identifier: Indiana University IRB )
• First Posted: October 6, 2020
• Last Update Posted: February 2, 2023
• Last Verified: February 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Digestive System Diseases