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

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.

Study Overview

• Status: Terminated
• Conditions: NAFLD; NASH - Nonalcoholic Steatohepatitis
• Intervention / Treatment: Diagnostic test: Velacur by Sonic Incytes

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Division of Gastroenterolgy and Hepatology

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Velacur by Sonic Incytes; 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; liver stiffness measurement

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of Velacur Measurements to Non-Invasive Blood Markers for Predicting Advanced Fibrosis	This was initially included in our study protocol as an outcome measurement. However, we realized that these markers were not being routinely collected and the data are simply not available. Therefore, no outcome data are or can be included for this measurement.	one day

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Sonic Incytes
• Investigators: Principal Investigator: Samer Gawrieh, MD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2021
• Primary Completion (Actual): April 26, 2022
• Study Completion (Actual): April 26, 2022

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: Liver Incytes for NAFLD; 2009698457 (Other Identifier: Indiana University IRB)

Drug and device information, study documents

• 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