FibroScan-Reproducibility and Repeatability Study (FibroScan-RR)

Echosens North America

Status: Invitation-only

Conditions: Liver Disease; Alcohol-Related; Non-Alcoholic Fatty Liver Disease

Treatments: Device: FibroScan; Other: Liver Enzymes

Study type: Interventional

Funder types: Industry

Identifiers

NCT06877026

M141

Details and patient eligibility

About

Chronic liver disease (CLD) is a serious health issue worldwide, often progressing without symptoms until advanced stages with risks of complications like liver cancer and cirrhosis. Early detection is crucial to help prevent these outcomes. Liver stiffness measurement (LSM) can detect fibrosis (scarring) in the liver, a common issue in CLD patients while traditional methods like liver biopsy are invasive and not ideal for regular screening and monitoring.

FibroScan, a non-invasive device, measures the liver stiffness and fat content in the liver. This study will assess how reliable and consistent FibroScan results are when used by different operators and across different days, focusing on patients with liver conditions like metabolic-related liver disease (MASLD), alcohol-related liver disease (ALD), and hepatitis B. This research also aims to test both the standard and Guided VCTE (Vibration Controlled Transient Elastography) FibroScan generations to evaluate their reproducibility and repeatability. As secondary objectives the Control Attenuation Parameter (CAP) results, and the FAST, Agile 3+, and Agile 4 scores will be evaluated to compare their reproducibility and repeatability.

Adult participants will attend two visits within three days. During these visits, they will undergo multiple FibroScan scans that include five scans on Day 1 (visit 1) and four scans on the follow up visit (visit 2), one blood sample for liver health assessment on each visit, and an AUDIT questionnaire on Day 1 (visit 1). Some participants may undergo only two scans on the follow-up visit since this will depend on operator availability. Each session will last 25-45 minutes including all examination types.

The study is funded by Echosens, the manufacturer of FibroScan, and will be conducted at UK healthcare facilities in England. By evaluating the variability of FibroScan results, this research could lead to a better understanding of the device's reproducibility and reliability in measuring liver stiffness across different operators and time points, potentially enhancing clinical confidence in its use for managing chronic liver diseases.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (age ≥ 18 y.o) with Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD), Metabolic and Alcohol-related Liver Disease (MetALD), and Alcohol-related Liver Disease (ALD).
• Adult patients able to give written informed consent.

Exclusion criteria

• Vulnerable patients
• Patients with other chronic liver disease including but not limited to hepatitis B, hepatitis C, autoimmune hepatitis, cholestatic diseases
• Patients with ascites
• Patients with elevated conjugated bilirubin (>1.5 ULN)
• Patients with heart failure

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

Full Cohort

Experimental group

Description:

This population will be defined by patients fulfilling all inclusion and exclusion criteria.

Treatment:

Other: Liver Enzymes

Device: FibroScan