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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)
• Intervention / Treatment: Device: Velacur

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jo Ann Gilbert; Phone Number: 972-637-8546; Email: JoAnn.Gilbert@GIAlliance.com

Study Locations

• United States
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • GI Alliance-Flowood, MS
      • Contact: Nolan Runnels, RN, BSN; Phone Number: 601-863-0395; Email: Nolan.Runnels@gastrodocs.net
  • Texas
    • Webster, Texas, United States, 77598
      • GI Alliance-Webster, TX
      • Contact: Tessa Kus, MPH; Phone Number: 281-699-1715; Email: Tessa.Kus@GIAlliance.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All sexes, 18-80 years old. Patients with Non-Alcoholic Fatty Liver Disease (NAFLD), including both those with Non-Alcoholic Fatty Liver (NAFL) and Non-Alcoholic Steatohepatitis (NASH).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-randomized, open-label study; All participants will have the same Laboratory and Diagnostic Assessments and Imaging Procedures.	Device: Velacur; Imaging Procedures Comparison; Other Names: Fibroscan; MRE/MRI

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elasticity and attenuation measurements from the Velacur system and BMI measurements (kg/m2)	Evaluate Velacur to measure liver stiffness and attenuation in patients of varying body composition	2024
Comparison of previously calculated cutoff, with new measurements.	Evaluate the cutoffs based on this cohort of patients, in comparison to previous cutoffs	2024

Collaborators and Investigators

• Sponsor: GI Alliance
• Collaborators: Sonic Incytes
• Investigators: Principal Investigator: Sri Naveen Surapaneni, MD, GI Alliance; Principal Investigator: Reed B Hogan, III, MD, GI Alliance

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2023
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Estimated): June 16, 2023

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: NASH; NAFL
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: Velacur-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes