Trial Outcomes & Findings for Quantitative Ultrasound With Liver Incytes for Evaluation of Non-Alcoholic Fatty Liver Disease (NCT NCT04576923)

Last Updated: 2023-08-21

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

one day

Results posted on

2023-08-21

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	36
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study 15 had scans that were determined to be invalid and these are not reported within the results.	15

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Velacur by Sonic Incytes n=21 Participants 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.
Age, Continuous	58 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants
BMI measured in kg/m^2	34.4 kg/m^2 STANDARD_DEVIATION 7.4 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Velacur by Sonic Incytes for Stage F0 n=2 Participants 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: F0	Velacur by Sonic Incytes for Stage F1 n=4 Participants 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	Velacur by Sonic Incytes for Stage F2 n=5 Participants 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	Velacur by Sonic Incytes for Stage F3 n=5 Participants 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	Velacur by Sonic Incytes for Stage F4 n=5 Participants 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
Liver Stiffness Measured by Velacur	9.8 kPa Standard Deviation 4.4	7.2 kPa Standard Deviation 2.3	7.4 kPa Standard Deviation 1.6	7.5 kPa Standard Deviation 1.9	10.5 kPa Standard Deviation 5.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Velacur by Sonic Incytes for Stage F0 n=2 Participants 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: F0	Velacur by Sonic Incytes for Stage F1 n=4 Participants 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	Velacur by Sonic Incytes for Stage F2 n=5 Participants 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	Velacur by Sonic Incytes for Stage F3 n=5 Participants 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	Velacur by Sonic Incytes for Stage F4 n=5 Participants 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
Liver Stiffness Measured by Transient Elastography	11.1 kPa Standard Deviation 4.3	10.1 kPa Standard Deviation 3.5	15.3 kPa Standard Deviation 8.3	7.5 kPa Standard Deviation 1.9	18.2 kPa Standard Deviation 9.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Velacur by Sonic Incytes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Samer Gawrieh, MD

Indiana University

Phone: 317-278-9326

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place