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

GI Alliance

Status: Not yet enrolling

Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)

Treatments: Device: Velacur

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05908006

Velacur-2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

non-randomized, open-label study

Description:

All participants will have the same Laboratory and Diagnostic Assessments and Imaging Procedures.

Treatment:

Device: Velacur