Liver Fibrosis, Liver Steatosis
Conditions
Keywords
liver, ultrasound elastography
Brief summary
Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis. To evaluate the discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements.
Detailed description
This will be a prospective, open label, feasibility and validation study of the Liver Incyte system in patients with liver fibrosis (Cohort 1, n = 150) and healthy volunteers (Cohort 2, n = 50), for a total of 200 participants. The physician operator of the FibroScan, and the operator of the Shear wave vibro-elastography (S-WAVE) system, will not be blinded to the clinical diagnoses of the patients. All patients will undergo the testing with both FibroScan and Liver Incyte system at a single in-clinic visit. The liver stiffness of each participant will be assessed with the Liver Incyte Model B device and with FibroScan. The elasticity measurements from these two devices will be the primary outcome measure. The Liver Incyte system is designed as two models with differences in the ultrasound components only, description of the two models is below. Two sub-studies are included in this design as exploratory objectives. Model B will be utilized at all study sites and all study participants. Participants at the LAIR study site will also be evaluated using Model A, as well as Model B, for verification and to confirm consistency between designs. Participants will have the option to participate in the Magnetic Resonance Elastography (MRE) and Proton Density Fat Fraction (PDFF) portion of the study. MRE/PDFF is an optional procedure, which makes up a sub-study for this trial, this would require approximately 1 hour, and is open to any participant who is willing and has time for the extra study visit. The results of the MRE/PDFF sub-study will be included as an exploratory objective.
Interventions
DEVICELiver Incyte
Ultrasound elasticity imaging
Sponsors
Sonic Incytes
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Any sex, ages 19-75 years inclusively * Individuals with a history of chronic Hepatitis C (HCV) or non-alcoholic steatohepatitis (NASH). Patients with history of Hepatitis C must have completed treatment and achieved Sustained viral response at 12 weeks (SVR12). * Previous FibroScan measurement (within the last 13 months) between 8 kilopascals and 35 kilopascals. * Able to understand the informed consent form, study procedures and willing to participate in study
Exclusion criteria
* Unable to achieve SVR12 with previous antiviral treatment for HCV * Multiple (\>1) liver disease diagnoses within the past 12 months * Co-infection with another Hepatitis virus or Human Immunodeficiency Virus (HIV), last testing within past 5 years * Documented or known ascites * Documented or known portal hypertension * BMI greater than 35 kg/m2 (30 kg/m2 for optional MRE participants) * If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding * Individuals with history of persistent ethanol abuse (alcohol consumption exceeding 2 standard drinks per day on average \[1 standard drink = 10 grams of alcohol\]) * Individuals with implanted electrical devices such as pacemakers, internal defibrillators, cochlear implants and nerve stimulators. * Individuals with surgically removed gallbladder (for optional MRE procedure only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discrimination of Healthy Volunteers From Patients With Liver Fibrosis | Baseline | The discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements. All measurements were collected at a single timepoint for each patient. Both measurements were collected on the same day. No longitudinal data was collected. An receiver operating characteristic (ROC) curve using final Liver Incyte elasticity measurement as a predictor of healthy versus fibrotic (HCV/NASH) will be constructed with accompanying 95% confidence interval for the area under the curve (AUC). The AUC and 95% confidence intervals for the FibroScan device will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the Device as Measured by Rate of Adverse Events | 4 weeks | The safety and tolerability of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis Total number of adverse events when using the investigational device will be reported. |
Countries
Canada, United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 47.5 years |
| Liver Incyte Elasticity | 4.9 kilopascals (kPa) STANDARD_DEVIATION 0.81 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Canada | 72 participants |
| Region of Enrollment United States | 68 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 54 |
| other Total, other adverse events | 0 / 86 | 0 / 54 |
| serious Total, serious adverse events | 0 / 86 | 0 / 54 |
Outcome results
None listed