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

NCT ID: NCT04576923

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-19
• Study Completion Date: 2022-04-26

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.

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.

Conditions

NAFLD; NASH - Nonalcoholic Steatohepatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Velacur by Sonic Incytes

Intervention Type: DIAGNOSTIC_TEST

liver stiffness measurement

Interventions

Velacur by Sonic Incytes

liver stiffness measurement

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sonic Incytes

INDUSTRY

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Samer Gawrieh

Professor of Clinical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samer Gawrieh, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2009698457

Identifier Type: OTHER

Identifier Source: secondary_id

Liver Incytes for NAFLD

Identifier Type: -

Identifier Source: org_study_id