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Completed

NCT Number: NCT06552377

Ultrasound and Attenuation Imaging

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non Alcoholic Fatty Liver Non-alcoholic Steatohepatitis Steatosis of Liver

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bronglais Hospital

Aberystwyth, Ceredigion, SY23 1ER, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old or over
  • General Practitioner (GP) and Outpatients (OP) referral
  • NAFLD, Unknown, Diabetes, Other metabolic disease

Exclusion criteria

  • Younger than 18 years old
  • Inpatients
  • Known large liver masses
  • Poor visualisation of the liver due to body type or anatomy.

Treatment and study plan

Ultrasound Attenuation imaging measurement

Device

Participant to undergo conventional ultrasound scanning with attenuation measurement as well.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Age of patient

    Time frame: all measurements obtained within single 30 minute appointment

    Age of patient

  2. Height

    Time frame: all measurements obtained within single 30 minute appointment

    Height, patients height measured immediately after scan.

  3. Weight

    Time frame: all measurements obtained within single 30 minute appointment

    Weight, patient weighed immediately after scan

  4. Diagnosis or Relevant history

    Time frame: all measurements obtained within single 30 minute appointment

    Diagnosis or relevant history from referral form.

Sponsors and collaborators

Lead sponsor

Hywel Dda Health Board

Other

Registry information

Official study title

A Cross-sectional Study Assessing the Agreement Between Sonographer Based Assessment of the Fatty Liver Using Conventional Ultrasound and Attenuation Imaging Scoring.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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