Effectiveness of Ultrasound in Liver Stiffness and Fat Quantification

NCT06111859 | Unknown

• 1 other identifier: 212836
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Liver stiffness is a marker for scarring of the liver, which occurs after damage from various liver conditions. Scarring prevents normal liver function and can lead to liver failure. Fatty liver is a common cause of liver damage and can contribute to scarring. Currently, liver biopsy serves as the 'gold standard' for assessing the degree of liver scarring and fatty infiltration, guiding treatment decisions. However, liver biopsy poses a significant risk of death and unpleasant side effects, including internal bleeding and pain. Moreover, due to the small sample of liver tissue obtained during the biopsy, the results can be misleading and may not provide an accurate overview of the liver's health. Therefore, there is an unmet need for a non-invasive method of measuring liver stiffness and fat content. Ultrasound-based methods utilize various properties of ultrasound waves to assess liver stiffness and fat levels. This study aims to recruit 100-120 patients with chronic liver disease. The investigators will assess liver stiffness and fat levels during patients' hospital visits for routine scans, biopsies, or clinic appointments. The resulting measurements of liver stiffness and fat obtained through ultrasound-based methods will be compared to patients' routine liver biopsies, routine FibroScan results (another non-invasive method routinely used in clinical care to assess patients' liver stiffness), and other non-invasive severity scores (calculated from results obtained from patients' routine blood tests, providing an overview of the extent of liver damage).

Conditions

Liver Disease Chronic; Fibrosis, Liver; Liver Steatoses; Liver Fat; NAFLD; NASH With Fibrosis; Hepatitis

Keywords

Elastography; Fat Quantification Liver; Chronic liver disease; NAFLD; MAFLD; Hepatitis; Cirrhosis

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy of liver elastography compared to histological staging

  Comparison of ultrasound elastography measures and biopsy based fibrosis scores

  3 years

• Diagnostic accuracy of liver fat quantification compared to histological assessment

  Comparison of ultrasound fat quantification measures and biopsy based fat percentages

  3 years

Study Arms (1)

Liver Biopsy Cohort

EXPERIMENTAL

Diagnostic Test: Ultrasound based Elastography and fat quantification

Interventions

Ultrasound based Elastography and fat quantification DIAGNOSTIC_TEST

Correlation of ultrasound-based elastography and fat quantification on liver biopsy

Liver Biopsy Cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=18 years old
• Male or Female
• Suspected chronic liver disease based on clinical history, serum biochemistry, prior imaging or prior liver biopsy
• Willing and able to provide written informed consent.

You may not qualify if:

• Liver transplantation within the last six months
• Suspected or known acute liver disease
• Focal liver lesion(s)
• Age \<18 years old
• Pregnant women

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Samsung Medison: collaborator

Study Sites (1)

Nuran Seneviratne

London, SE13 5FX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Fatty Liver; Non-alcoholic Fatty Liver Disease; Hepatitis; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cheng Fang

CONTACT

07809747718; chengfang@nhs.net

Paul Sidhu

CONTACT

paulsidhu@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: November 1, 2023
• Study Start: January 2, 2023
• Primary Completion: January 2, 2025
• Study Completion: July 2, 2025
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)