NAFLD, NASH - Nonalcoholic Steatohepatitis
Conditions
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.
Interventions
DIAGNOSTIC_TESTVelacur by Sonic Incytes
liver stiffness measurement
Sponsors
Sonic Incytes
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
This is an open label study in that all participants will receive the same study procedures.
Intervention model description
All participants will undergo quantitative ultrasound with Liver Incytes by a certified technician.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Stiffness Measured by Velacur | one day | 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 | one day | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Velacur Measurements to Non-Invasive Blood Markers for Predicting Advanced Fibrosis | one day | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 15 had scans that were determined to be invalid and these are not reported within the results. | 15 |
Baseline characteristics
| Characteristic | Velacur by Sonic Incytes |
|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 11.9 |
| BMI measured in kg/m^2 | 34.4 kg/m^2 STANDARD_DEVIATION 7.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
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.
Time frame: one day
Population: 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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Velacur by Sonic Incytes for Stage F0 | Liver Stiffness Measured by Transient Elastography | 11.1 kPa | Standard Deviation 4.3 |
| Velacur by Sonic Incytes for Stage F1 | Liver Stiffness Measured by Transient Elastography | 10.1 kPa | Standard Deviation 3.5 |
| Velacur by Sonic Incytes for Stage F2 | Liver Stiffness Measured by Transient Elastography | 15.3 kPa | Standard Deviation 8.3 |
| Velacur by Sonic Incytes for Stage F3 | Liver Stiffness Measured by Transient Elastography | 7.5 kPa | Standard Deviation 1.9 |
| Velacur by Sonic Incytes for Stage F4 | Liver Stiffness Measured by Transient Elastography | 18.2 kPa | Standard Deviation 9.1 |
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.
Time frame: one day
Population: 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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Velacur by Sonic Incytes for Stage F0 | Liver Stiffness Measured by Velacur | 9.8 kPa | Standard Deviation 4.4 |
| Velacur by Sonic Incytes for Stage F1 | Liver Stiffness Measured by Velacur | 7.2 kPa | Standard Deviation 2.3 |
| Velacur by Sonic Incytes for Stage F2 | Liver Stiffness Measured by Velacur | 7.4 kPa | Standard Deviation 1.6 |
| Velacur by Sonic Incytes for Stage F3 | Liver Stiffness Measured by Velacur | 7.5 kPa | Standard Deviation 1.9 |
| Velacur by Sonic Incytes for Stage F4 | Liver Stiffness Measured by Velacur | 10.5 kPa | Standard Deviation 5 |
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.
Time frame: one day
Population: 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.