Validation Study of the Velacur System in Comparison to MRE & MRI-PDFF in Patients With (Suspected) Liver Disease

Study Overview
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Brief Summary
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The goal of this open-label, non-randomized, prospective study is to compare Velacur and MRE in all sexes, 18-80 years old with Non-Alcoholic Fatty Liver Disease (NAFLD). The main aims is to: Validate the use of Velacur and elastography cut offs in a patient cohort with all types of chronic liver disease, against MRE results for fibrosis staging. Validate the use of Velacur and attenuation cut offs in a patient cohort with all types of chronic liver disease, against MRI-PDFF results for steatosis staging. Participants will Study participants will attend 1 study visit, in which measurement of liver stiffness with Velacur and FibroScan, will be performed by a certified technician. As part of Visit 1, Patients will also complete an MRI exam which will include both MRE and MRI-PDFF measurements (MRI imaging can take place within 28 days of the Velacur scan).

Detailed Description
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This will be a prospective, open label, validation study of the Velacur system in comparison to MRE and MRI-PDFF in patients with liver disease or suspected liver disease. Approximately 100 subjects may be enrolled in this study. Participants should span all levels of fibrosis and steatosis. The study is comprised of: Screening Period (up to 8 days) and Visit 1. There are no safety follow-up visits in this study. The primary objective of the study is to compare the results of Velacur against MRE and MRI-PDFF results for liver stiffness and steatosis. As part of prior studies, using MRE as the gold standard, clinical cut-off for Velacur have been developed. The primary objective of this study is to validate these cut-offs to see if Velacur can correctly classify patients. Secondary objectives include correlating the stiffness and attenuation results of Velacur with other clinical measures of fibrosis and steatosis such as Fib-4, and correlations with other clinical measurements collected through clinical care or clinical trials, such as Enhance Liver Fibrosis (ELF) test, FibroScan, MRI, or ultrasound based shear wave elastography (SWE) as they are available.

Official Title
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Comparison of Steatosis and Fibrosis Measurements From Velacur and MRE/MRI-PDFF in Patients With Chronic Liver Disease

Conditions
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Non-alcoholic Fatty Liver Disease (NAFLD)

Intervention / Treatment
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* Device: Velacur


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with evidence of NAFLD or other chronic liver disease such as one of the following: Biopsy proven chronic liver disease OR Evidence of hepatic steatosis or chronic liver disease on non-invasive assessment by one or more of the following criteria: Abdominal ultrasound within 12 months MRI-PDFF (greater than 12%) within 12 months FibroScan CAP score > 230 dB/m within 12 months OR At least 2 criteria for metabolic syndrome and increased stiffness on FibroScan (>8kPa) within 12 months Exclusion Criteria: BMI greater than 40 kg/m2 (or unable to fit into MRI bore) Subject with current, significant alcohol consumption or history of significant alcohol consumption Subjects with evidence of decompensated liver disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-randomized, open-label study<br>All participants will have the same Laboratory and Diagnostic Assessments and Imaging Procedures. | Device: Velacur<br>* Imaging Procedures Comparison<br>* Other names: Fibroscan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elasticity measurements | Validate the use of Velacur and elastography cut offs with all types of chronic liver disease, against MRE results for fibrosis staging. The liver tissue elasticity is measured in kilopascals (kPa), using Velacur. The Velacur elasticity measurements will be compared to those from Magnetic Resonance Elastography, which is measuring liver tissue elasticity in kilopascals (kPa). | 2024 | 
| Attenuation measurement | Validate the use of Velacur and attenuation cut offs with all types of chronic liver disease, against MRI-PDFF results for steatosis staging. Ultrasound attenuation is a quantitative measurement of ultrasound image parameters. Attenuation is measured by Velacur, and uses units of of decibels per meter (dB/m). These numbers are compared to the fat percentage as measured by MRI proton density fat fraction, which is measured in percentage fat (%). | 2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum markers such as Fib-4, APRI and NALFD Fibrosis score or ELF (enhanced liver fibrosis) score. | Comparison of Velacur stiffness and attenuation results with other clinical measures of fibrosis and steatosis, such as blood work, using readily available scores and attenuation results with other clinical measures of fibrosis and steatosis, such as blood work, using readily available scores. | 2024 | 
| The combined outputs of elasticity and attenuation from Velacur and FibroScan | Discriminatory ability of Velacur compared with other noninvasive markers, such as FibroScan | 2024 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NASH, NAFL