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

Primary Purpose

NAFLD, NASH - Nonalcoholic Steatohepatitis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Velacur by Sonic Incytes

About this trial

This is an interventional diagnostic trial for NAFLD

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
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).
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

Sites / Locations

Indiana University Division of Gastroenterolgy and Hepatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Velacur by Sonic Incytes

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04576923

First Posted

September 30, 2020

Last Updated

August 18, 2023

Sponsor

Indiana University

Collaborators

Sonic Incytes

1. Study Identification

Unique Protocol Identification Number

NCT04576923

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Terminated

Why Stopped

Lack of coordinator resources

Study Start Date

March 19, 2021 (Actual)

Primary Completion Date

April 26, 2022 (Actual)

Study Completion Date

April 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

Sonic Incytes

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NAFLD, NASH - Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

Allocation

N/A

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Velacur by Sonic Incytes

Arm Type

Experimental

Arm Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Velacur by Sonic Incytes

Intervention Description

liver stiffness measurement

Primary Outcome Measure Information:

Title

Liver Stiffness Measured by Velacur

Description

Time Frame

one day

Title

Liver Stiffness Measured by Transient Elastography

Description

Time Frame

one day

Other Pre-specified Outcome Measures:

Title

Correlation of Velacur Measurements to Non-Invasive Blood Markers for Predicting Advanced Fibrosis

Description

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.

Time Frame

one day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samer Gawrieh, MD

Organizational Affiliation

Indiana University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University Division of Gastroenterolgy and Hepatology

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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