Quantitative Ultrasound With Liver Incytes for Evaluation of Non-Alcoholic Fatty Liver Disease
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|ClinicalTrials.gov Identifier: NCT04576923|
Recruitment Status : Active, not recruiting
First Posted : October 6, 2020
Last Update Posted : February 2, 2023
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|Condition or disease||Intervention/treatment||Phase|
|NAFLD NASH - Nonalcoholic Steatohepatitis||Diagnostic Test: Liver Incytes||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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.|
|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|
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
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04576923
|United States, Indiana|
|Indiana University Division of Gastroenterolgy and Hepatology|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Samer Gawrieh, MD||Indiana University School of Medicine|
|Responsible Party:||Samer Gawrieh, Associate Professor of Clinical Medicine, Indiana University|
|Other Study ID Numbers:||
Liver Incytes for NAFLD
2009698457 ( Other Identifier: Indiana University IRB )
|First Posted:||October 6, 2020 Key Record Dates|
|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|
Non-alcoholic Fatty Liver Disease
Digestive System Diseases