Clinical trial NCT05908006: Validation Study of the Velacur System in Comparison to MRE & MRI-PDFF in Patients With (Suspected) Liver Disease
Official title: Comparison of Steatosis and Fibrosis Measurements From Velacur and MRE/MRI-PDFF in Patients With Chronic Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)
Keywords: NASH
NAFL
Lead sponsor: GI Alliance
Sponsor class: OTHER
Collaborators: name: Sonic Incytes
First posted: 2023-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Elasticity measurements
timeFrame: 2024
measure: Attenuation measurement
timeFrame: 2024
Secondary outcomes:
measure: Serum markers such as Fib-4, APRI and NALFD Fibrosis score or ELF (enhanced liver fibrosis) score.
timeFrame: 2024
measure: The combined outputs of elasticity and attenuation from Velacur and FibroScan
timeFrame: 2024
Other outcomes:
measure: Elasticity and attenuation measurements from the Velacur system and BMI measurements (kg/m2)
timeFrame: 2024
measure: Comparison of previously calculated cutoff, with new measurements.
timeFrame: 2024
Locations:
city: Flowood
country: United States
facility: GI Alliance-Flowood, MS
state: Mississippi
city: Webster
country: United States
facility: GI Alliance-Webster, TX
state: Texas
Study officials:
affiliation: GI Alliance
name: Sri Naveen Surapaneni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GI Alliance
name: Reed B Hogan, III, MD
role: PRINCIPAL_INVESTIGATOR
References: