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

NCT04576923 | Terminated Results FDA Device

• 2 other identifiers: Liver Incytes for NAFLD2009698457
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD; NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  one day

Study Arms (1)

Velacur by Sonic Incytes

EXPERIMENTAL

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

Interventions

Velacur by Sonic Incytes DIAGNOSTIC_TEST

liver stiffness measurement

Velacur by Sonic Incytes

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Sonic Incytes: collaborator

Study Sites (1)

Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Samer Gawrieh, MD
• Organization: Indiana University

sgawrieh@iu.edu

317-278-9326

Study Officials

• Samer Gawrieh, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open label study in that all participants will receive the same study procedures.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Model Details: All participants will undergo quantitative ultrasound with Liver Incytes by a certified technician.

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 6, 2020
• Study Start: March 19, 2021
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2023-08

Locations

US (1)