- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06111859
Effectiveness of Ultrasound in Liver Stiffness and Fat Quantification
Real-time Elastography for Non-invasive Assessment of Liver Fibrosis and Fat Quantification Techniques for Assessment of Fatty Change in Chronic Liver Disease
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cheng Fang
- Phone Number: 07809747718
- Email: chengfang@nhs.net
Study Contact Backup
- Name: Paul Sidhu
- Email: paulsidhu@nhs.net
Study Locations
-
-
-
London, United Kingdom, SE13 5FX
- Recruiting
- Nuran Seneviratne
-
Contact:
- Nuran Seneviratne
- Phone Number: 07494154488
- Email: nuran.seneviratne@nhs.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- >=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.
Exclusion Criteria:
- Liver transplantation within the last six months
- Suspected or known acute liver disease
- Focal liver lesion(s)
- Age <18 years old
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liver Biopsy Cohort
|
Correlation of ultrasound-based elastography and fat quantification on liver biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy of liver elastography compared to histological staging
Time Frame: 3 years
|
Comparison of ultrasound elastography measures and biopsy based fibrosis scores
|
3 years
|
Diagnostic accuracy of liver fat quantification compared to histological assessment
Time Frame: 3 years
|
Comparison of ultrasound fat quantification measures and biopsy based fat percentages
|
3 years
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 212836
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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