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

Status unconfirmed

Conditions studied: Non-alcoholic Fatty Liver Disease (NAFLD)

In brief

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).

Key facts

Study ID

NCT05908006

Run by

GI Alliance

People needed

100

Starts

2023-07-15

Expected to finish

2024-01-31

Last updated by the study team

2023-06-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GI Alliance-Flowood, MS — Flowood, Mississippi, United States
• GI Alliance-Webster, TX — Webster, Texas, United States

Full record on ClinicalTrials.gov

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