Non-Alcoholic Fatty Liver DiseaseNCT06552377
Ultrasound and Attenuation Imaging
An observational study of Non-Alcoholic Fatty Liver Disease and Non Alcoholic Fatty Liver, run by Hywel Dda Health Board at 1 site in United Kingdom.
Trial summary
Fatty liver disease affects almost a 3rd of the United Kingdom (UK) population. Currently, this is being investigated using a type of MRI scan that reports how fatty or not a person's liver is, with a liver fat score, but many patients cannot have this type of scan due to time, cost or because they have a condition… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, Non-alcoholic Steatohepatitis
- What is being tested?
- Ultrasound Attenuation imaging measurement
- Type of treatment
- Medical device
- How many people
- 97 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2024to 11 Apr 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population will be of patients having liver scans or abdominal scans including the liver at Bronglais Hospital, Aberystwyth during the period the study.
Who may be able to join
- 18 years old or over
- General Practitioner (GP) and Outpatients (OP) referral
- NAFLD, Unknown, Diabetes, Other metabolic disease
Who cannot join
- Younger than 18 years old
- Inpatients
- Known large liver masses
- Poor visualisation of the liver due to body type or anatomy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bronglais Hospital
Aberystwyth, Ceredigion, SY23 1ER
About this study
Official title: A Cross-sectional Study Assessing the Agreement Between Sonographer Based Assessment of the Fatty Liver Using Conventional Ultrasound and Attenuation Imaging Scoring.
Fatty liver disease affects almost a 3rd of the United Kingdom (UK) population. Currently, this is being investigated using a type of MRI scan that reports how fatty or not a person's liver is, with a liver fat score, but many patients cannot have this type of scan due to time, cost or because they have a condition which makes Magnetic Resonance Imaging (MRI) an unsafe scan for them to have. An ultrasound scan is cheaper, faster and safer for a wider variety of patients. New developments in ultrasound technology mean that instead of a Sonographer, or ultrasound operator, deciding whether your liver is fatty or not based on what they see on the scan, the ultrasound machine gives a liver fat score. This study will look at the relationship between the Sonographers' view on how fatty the liver is, compared with the liver fat score given by the new development in ultrasound technology.
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) affects almost a 3rd of the population of the UK and current best practice is to evaluate this using Magnetic Resonance Imaging proton density fat fraction (MRI PDFF), however, this is inaccessible to many patients due to limited availability, cost and a large exclusion criteria. Ultrasound offers an affordable, faster and more inclusive method of liver evaluation but only subjective assessment of fatty liver disease until a recent development- Attenuation Imaging (AI). Attenuation imaging gives a numerical score for fatty liver disease. Attenuation imaging has previously only been compared to MRI PDFF, however, when many patients do not have MRI PDFF it is essential to compare it to common practice, conventional ultrasound. This study aims to assess the agreement between conventional ultrasound assessment of the liver and AI using a cross-sectional method. Convenience sampling will be used to select 95 participants who will have their AI score carried out alongside their routine ultrasound scan with the sonographer blinded to the AI results. The inter-rater agreement will be determined using Kappa statistics. The results will demonstrate the strength of relationship between the two methods. A strong agreement between the two may facilitate further investigation into the uses of AI, such as use as a teaching tool or in aiding decisions in cases that Sonographers find more difficult to assess such as those patients with a high BMI.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, Non-alcoholic Steatohepatitis, Steatosis of Liver
- Being tested
- Ultrasound Attenuation imaging measurement
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Attenuation imaging measurementDevice
Participant to undergo conventional ultrasound scanning with attenuation measurement as well.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Ultrasound attenuation imaging measurement Receives: Device: Ultrasound Attenuation imaging measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonographer assessment of the liver
Sonographers grade the liver normal, mild, moderate, severe fatty liver dependent on factors including hepatorenal contrast, visualisation of vessel borders and of diaphragm.
Measured: all measurements obtained within single 30 minute appointment
Measurement of liver fat using attenuation imaging
Sonographer uses attenuation imaging function to measure liver fd
Measured: all measurements obtained within single 30 minute appointment
Secondary outcomes (4)
Age of patient
Age of patient
Measured: all measurements obtained within single 30 minute appointment
Height
Height, patients height measured immediately after scan.
Measured: all measurements obtained within single 30 minute appointment
Weight
Weight, patient weighed immediately after scan
Measured: all measurements obtained within single 30 minute appointment
Diagnosis or Relevant history
Diagnosis or relevant history from referral form.
Measured: all measurements obtained within single 30 minute appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start14 Feb 2024
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hywel Dda Health Board
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552377
- Sponsor's protocol ID
- IRAS 329847
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study Assessing the Agreement Between Sonographer Based Assessment of the Fatty Liver Using Conventional Ultrasound and Attenuation Imaging Scoring.
- ClinicalTrials.gov ID
- NCT06552377
- Acronym / sponsor ID
- IRAS 329847
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, Non-alcoholic Steatohepatitis, Steatosis of Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Hywel Dda Health BoardUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 14 Aug 2024 (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.
Fatty liver disease affects almost a 3rd of the United Kingdom (UK) population. Currently, this is being investigated using a type of MRI scan that reports how fatty or not a person's liver is, with a liver fat score, but many patients cannot have this type of scan due to time, cost or because they have a condition which makes Magnetic Resonance Imaging (MRI) an unsafe scan for them to have. An ultrasound scan is cheaper, faster and safer for a wider variety of patients. New developments in ultrasound technology mean that instead of a Sonographer, or ultrasound operator, deciding whether your liver is fatty or not based on what they see on the scan, the ultrasound machine gives a liver fat score. This study will look at the relationship between the Sonographers' view on how fatty the liver is, compared with the liver fat score given by the new development in ultrasound technology.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) affects almost a 3rd of the population of the UK and current best practice is to evaluate this using Magnetic Resonance Imaging proton density fat fraction (MRI PDFF), however, this is inaccessible to many patients due to limited availability, cost and a large exclusion criteria. Ultrasound offers an affordable, faster and more inclusive method of liver evaluation but only subjective assessment of fatty liver disease until a recent development- Attenuation Imaging (AI). Attenuation imaging gives a numerical score for fatty liver disease. Attenuation imaging has previously only been compared to MRI PDFF, however, when many patients do not have MRI PDFF it is essential to compare it to common practice, conventional ultrasound. This study aims to assess the agreement between conventional ultrasound assessment of the liver and AI using a cross-sectional method. Convenience sampling will be used to select 95 participants who will have their AI score carried out alongside their routine ultrasound scan with the sonographer blinded to the AI results. The inter-rater agreement will be determined using Kappa statistics. The results will demonstrate the strength of relationship between the two methods. A strong agreement between the two may facilitate further investigation into the uses of AI, such as use as a teaching tool or in aiding decisions in cases that Sonographers find more difficult to assess such as those patients with a high BMI.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Device: Ultrasound Attenuation imaging measurementUltrasound attenuation imaging measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be of patients having liver scans or abdominal scans including the liver at Bronglais Hospital, Aberystwyth during the period the study.
Key inclusion criteria (3 listed)
- 18 years old or over
- General Practitioner (GP) and Outpatients (OP) referral
- NAFLD, Unknown, Diabetes, Other metabolic disease
Key exclusion criteria (4 listed)
- Younger than 18 years old
- Inpatients
- Known large liver masses
- Poor visualisation of the liver due to body type or anatomy.
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 Attenuation imaging measurementParticipant to undergo conventional ultrasound scanning with attenuation measurement as well. | Device | All participants |
Primary outcome
Sonographer assessment of the liver
Time frame: all measurements obtained within single 30 minute appointment
Sonographers grade the liver normal, mild, moderate, severe fatty liver dependent on factors including hepatorenal contrast, visualisation of vessel borders and of diaphragm.
Measurement of liver fat using attenuation imaging
Time frame: all measurements obtained within single 30 minute appointment
Sonographer uses attenuation imaging function to measure liver fd
4 secondary outcomes
Age of patient
Time frame: all measurements obtained within single 30 minute appointment
Height
Time frame: all measurements obtained within single 30 minute appointment
Weight
Time frame: all measurements obtained within single 30 minute appointment
Diagnosis or Relevant history
Time frame: all measurements obtained within single 30 minute appointment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease and Non Alcoholic Fatty Liver, run by Hywel Dda Health Board 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 22 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sonographer assessment of the liver (time frame: all measurements obtained within single 30 minute appointment). 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 22 Aug 2024.