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| ID | Type | Description | Link |
|---|---|---|---|
| 2009698457 | Other Identifier | Indiana University IRB |
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Lack of coordinator resources
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| Name | Class |
|---|---|
| Sonic Incytes | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Velacur by Sonic Incytes | Diagnostic Test | liver stiffness measurement |
|
| 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 |
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| 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 |
Inclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Samer Gawrieh, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Division of Gastroenterolgy and Hepatology | Indianapolis | Indiana | 46202 | United States |
Of the 36 participants who enrolled in the study, only 21 people had a valid Velacur study and valid ultrasound elasticity imaging. All 36 people completed the study but 15 people were later found to have results that were deemed to not be valid upon review by Sonic Incytes.
Of the 36 participants who enrolled in the study, only 21 people had a valid Velacur study and valid ultrasound elasticity imaging. All 36 people completed the study but 15 people were later found to have results that were deemed to not be valid upon review by Sonic Incytes.
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| ID | Title | Description |
|---|---|---|
| FG000 | Velacur by Sonic Incytes | Patients with known or suspected Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH) will be scanned with Liver Incytes. Of the 36 participants who enrolled in the study, only 21 people had a valid Velacur study and valid ultrasound elasticity imaging. All 36 people completed the study but 15 people were later found to have results that were deemed to not be valid upon review by Sonic Incytes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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A total of 21 people underwent both Velacur and transient elastography via FibroScan and had results considered to be reliable.
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| ID | Title | Description |
|---|---|---|
| BG000 | Velacur by Sonic Incytes | Patients with known or suspected Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH) will be scanned with Liver Incytes. Of the 36 participants who enrolled in the study, only 21 people had a valid Velacur study and valid ultrasound elasticity imaging. All 36 people completed the study but 15 people were later found to have results that were deemed to not be valid upon review by Sonic Incytes. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Of the 36 enrolled participants, 21 were determined to have results that were considered to be reliable for both the Velacur and transient elastography via FibroScan and underwent a liver biopsy less than 6 months prior to the Velacur and FibroScan measurements. Results are reported for two participants with F0 biopsy results. | Posted | Median | Standard Deviation | kPa | one day |
|
Adverse events were collected for the duration of study participation. This is a minimal risk study with only one study visit lasting less than one hour.
The definition of adverse event utilized in this trial correlates with the clincialtrials.gov definition of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Velacur by Sonic Incytes | Patients with known or suspected Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH) will be scanned with Liver Incytes. Of the 36 participants who enrolled in the study, only 21 people had a valid Velacur study and valid ultrasound elasticity imaging. All 36 people completed the study but 15 people were later found to have results that were deemed to not be valid upon review by Sonic Incytes. Adverse events were collected for the duration of study participation. This is a minimal risk study with only one study visit lasting less than one hour. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samer Gawrieh, MD | Indiana University | 317-278-9326 | sgawrieh@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2021 | Jul 26, 2023 | Prot_006.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 8, 2021 | Jul 26, 2023 | SAP_007.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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All participants will undergo quantitative ultrasound with Liver Incytes by a certified technician.
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This is an open label study in that all participants will receive the same study procedures.
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI measured in kg/m^2 | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Velacur by Sonic Incytes for Stage F1 | Patients with known or suspected Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH) will be scanned with Velacur and FibroScan and results will be compared to historical liver biopsy results. Liver biopsy was completed within 6 months of the Velacur and Fibroscan measurements. Results are reported for each group as determined by staging on liver biopsy: F1 |
| OG002 | Velacur by Sonic Incytes for Stage F2 | Patients with known or suspected Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH) will be scanned with Velacur and FibroScan and results will be compared to historical liver biopsy results. Liver biopsy was completed within 6 months of the Velacur and Fibroscan measurements. Results are reported for each group as determined by staging on liver biopsy: F2 |
| OG003 | Velacur by Sonic Incytes for Stage F3 | Patients with known or suspected Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH) will be scanned with Velacur and FibroScan and results will be compared to historical liver biopsy results. Liver biopsy was completed within 6 months of the Velacur and Fibroscan measurements. Results are reported for each group as determined by staging on liver biopsy: F3 |
| OG004 | Velacur by Sonic Incytes for Stage F4 | Patients with known or suspected Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH) will be scanned with Velacur and FibroScan and results will be compared to historical liver biopsy results. Liver biopsy was completed within 6 months of the Velacur and Fibroscan measurements. Results are reported for each group as determined by staging on liver biopsy: F4 |
|
|
| Primary | 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. | Of the 36 enrolled participants, 21 were determined to have results that were considered to be reliable for both the Velacur and transient elastography via FibroScan and underwent a liver biopsy less than 6 months prior to the Velacur and FibroScan measurements. Results are reported for two participants with F0 biopsy results. | Posted | Median | Standard Deviation | kPa | one day |
|
|
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| Other Pre-specified | 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. | During the conduct of this trial, we realized that these markers were not being routinely collected. For this study, no data for these markers were collected and are thus not available. As a result, no outcome data are or can be included for this measurement for any of the stages. | Posted | one day |
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| 36 |
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| 36 |
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| 36 |
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