FibroScan-Reproducibility and Repeatability Study

NCT ID: NCT06877026

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-19
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Full Cohort

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

Group Type: EXPERIMENTAL

FibroScan

Intervention Type: DEVICE

Day 1 = 5 FibroScan examinations Day 2 = 4 FibroScan examinations

Liver Enzymes

Intervention Type: OTHER

Day = 1 blood collection for liver enzymes. Day 2= 1 blood collection for liver enzymes.

Interventions

FibroScan

Day 1 = 5 FibroScan examinations Day 2 = 4 FibroScan examinations

Intervention Type: DEVICE

Liver Enzymes

Day = 1 blood collection for liver enzymes. Day 2= 1 blood collection for liver enzymes.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Echosens

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

King's College Hospital NHS Foundation Trust

London, England, United Kingdom

Countries

United Kingdom

Other Identifiers

M141

Identifier Type: -

Identifier Source: org_study_id