Liver Disease ChronicNCT06111859
Effectiveness of Ultrasound in Liver Stiffness and Fat Quantification
A study testing Ultrasound based Elastography and fat quantification in people with Liver Disease Chronic and Fibrosis, Liver, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Liver Disease Chronic, Fibrosis, Liver, Liver Steatoses
- What is being tested?
- Ultrasound based Elastography and fat quantification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jan 2023to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=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.
Who cannot join
- Liver transplantation within the last six months
- Suspected or known acute liver disease
- Focal liver lesion(s)
- Age <18 years old
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Paul Sidhu contact
United Kingdom1 site, 1 recruiting
- Recruiting
Nuran Seneviratne
London, SE13 5FX
Nuran Seneviratne, 07494154488, nuran.seneviratne@nhs.net
About this study
Official title: 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).
Read the 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
- Being tested
- Ultrasound based Elastography and fat quantification
- Keywords
- Elastography, Fat Quantification Liver, Chronic liver disease, NAFLD, MAFLD, Hepatitis, Cirrhosis
- Medical subject headings
- Liver Cirrhosis, Fatty Liver, Non-alcoholic Fatty Liver Disease, Hepatitis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound based Elastography and fat quantificationDiagnostic test
Correlation of ultrasound-based elastography and fat quantification on liver biopsy
| Study group | Role | What they receive |
|---|---|---|
| Liver Biopsy Cohort | Experimental | Not described Receives: Diagnostic Test: Ultrasound based Elastography and fat quantification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of liver elastography compared to histological staging
Comparison of ultrasound elastography measures and biopsy based fibrosis scores
Measured: 3 years
Diagnostic accuracy of liver fat quantification compared to histological assessment
Comparison of ultrasound fat quantification measures and biopsy based fat percentages
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start2 Jan 2023
- Primary completion2 Jan 2025 (estimated)
- Study completion2 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Disease ChronicStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medison
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111859
- Sponsor's protocol ID
- 212836
- Status last verified
- Oct 2023
- First submitted
- 14 Sep 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Elastography for Non-invasive Assessment of Liver Fibrosis and Fat Quantification Techniques for Assessment of Fatty Change in Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT06111859
- Acronym / sponsor ID
- 212836
- Conditions
- Liver Disease Chronic, Fibrosis, Liver, Liver Steatoses, Liver Fat, NAFLD, NASH With Fibrosis
- Keywords
- Elastography, Fat Quantification Liver, Chronic liver disease, NAFLD, MAFLD, Hepatitis, Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Samsung Medison
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 2 Jan 2025 (estimated)
- Study completion
- 2 Jul 2025 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Biopsy Cohort | Experimental | Diagnostic Test: Ultrasound based Elastography and fat quantification |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >=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.
Key exclusion criteria (5 listed)
- Liver transplantation within the last six months
- Suspected or known acute liver disease
- Focal liver lesion(s)
- Age <18 years old
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound based Elastography and fat quantificationCorrelation of ultrasound-based elastography and fat quantification on liver biopsy | Diagnostic test | Liver Biopsy Cohort |
Primary outcome
Diagnostic accuracy of liver elastography compared to histological staging
Time frame: 3 years
Comparison of ultrasound elastography measures and biopsy based fibrosis scores
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Sidhu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound based Elastography and fat quantification in people with Liver Disease Chronic and Fibrosis, Liver, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng Fang (07809747718, chengfang@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of liver elastography compared to histological staging (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.