Effectiveness of Ultrasound in Liver Stiffness and Fat Quantification

NCT ID: NCT06111859

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-02
• Study Completion Date: 2025-07-02

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).

Detailed Description

Elastography and fat quantification techniques are imaging methods integrated into the normal B-mode ultrasound. These techniques are extremely safe, with no additional risk compared to a normal ultrasound study. The advantage of using liver elastography/fat techniques to assess the degree of liver fibrosis/fatty change is that the techniques are non-invasive (no needles or biopsies) with higher patient acceptance and compliance. Shear wave elastography is a non-invasive technique that can quantify liver stiffness by measuring the speed of shear waves in the tissue of interest. Early studies have shown that the speed of the shear wave is closely associated with different stages of liver fibrosis. It has also been shown that the measurements can be reproduced by different investigators. Fatty changes, assessed by measurements called TAI, TSI, and EzHRI, are in the early stages of investigation and are proving to be robust. Early studies are mostly performed using elastography have been investigated using Fibroscan (vibration shear wave generator) techniques, and to a lesser extent using point and 2-D shearwave elastography. Fat quantification is also undertaken on the Fibroscan system, producing a Controlled Attenuation Parameter (CAP) measurement which can be correlated both to the fat quantification methods and biopsy result. The investigators have, through a previous project, demonstrated that liver stiffness, using point shear wave, on other machines can accurately identify different stages of liver fibrosis. The investigators would like to extend the study to include a further commercially available machine, namely Samsung RS85 Prestige, to study its diagnostic accuracy of point and 2-D elastography and the fat quantification techniques. As more machines with similar capabilities for stiffness and fat assessment become available, data would be collected from these also. In addition, this study will enrich scientific evidence in terms of how accurate elastography/fat assessment is as a method of measuring liver stiffness/fatty change and hopefully reduce the need to perform liver biopsy in the future.

Conditions

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

Study Design

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

Study Groups

Liver Biopsy Cohort

Group Type: EXPERIMENTAL

Ultrasound based Elastography and fat quantification

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Ultrasound based Elastography and fat quantification

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. >=18 years old

2. Male or Female

3. Suspected chronic liver disease based on clinical history, serum biochemistry, prior imaging or prior liver biopsy

4. Willing and able to provide written informed consent.

Exclusion Criteria

1. Liver transplantation within the last six months

2. Suspected or known acute liver disease

3. Focal liver lesion(s)

4. Age <18 years old

5. Pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medison

INDUSTRY

Sponsor Role: collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nuran Seneviratne

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Cheng Fang

Role: CONTACT

chengfang@nhs.net

07809747718

Paul Sidhu

Role: CONTACT

paulsidhu@nhs.net

Facility Contacts

Nuran Seneviratne

Role: primary

nuran.seneviratne@nhs.net

07494154488

Other Identifiers

212836

Identifier Type: -

Identifier Source: org_study_id