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

Non-alcoholic Fatty Liver Disease (NAFLD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05908006
• Other study ID #: Velacur-2
• Status: Not yet recruiting
• Start date: July 15, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: June 2023
• Source: GI Alliance
• Contact: Jo Ann Gilbert
• Phone: 972-637-8546
• Email: JoAnn.Gilbert[@]GIAlliance.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 31, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease (NAFLD)

Intervention

Device:
• Velacur
Imaging Procedures Comparison

Locations

Country	Name	City	State
United States	GI Alliance-Flowood, MS	Flowood	Mississippi
United States	GI Alliance-Webster, TX	Webster	Texas

Sponsors (2)

Lead Sponsor	Collaborator
GI Alliance	Sonic Incytes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Comparison of previously calculated cutoff, with new measurements.	Evaluate the cutoffs based on this cohort of patients, in comparison to previous cutoffs	2024
Primary	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
Primary	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	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
Secondary	The combined outputs of elasticity and attenuation from Velacur and FibroScan	Discriminatory ability of Velacur compared with other noninvasive markers, such as FibroScan	2024