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Effectiveness of Ultrasound in Liver Stiffness and Fat Quantification

NCT06111859 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-11-01

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Ultrasound based Elastography and fat quantification

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

Sponsors & Collaborators

  • Samsung Medison

    collaborator INDUSTRY

  • King's College Hospital NHS Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-02
Primary Completion
2025-01-02
Completion
2025-07-02

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06111859 on ClinicalTrials.gov