Ultrasound and Attenuation Imaging

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.

Study Overview

• Status: Completed
• Conditions: Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; Non Alcoholic Fatty Liver; Steatosis of Liver
• Intervention / Treatment: Device: Ultrasound Attenuation imaging measurement

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 Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• United Kingdom
  • Ceredigion
    • Aberystwyth, Ceredigion, United Kingdom, SY23 1ER
      • Bronglais Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants; Ultrasound attenuation imaging measurement	Device: Ultrasound Attenuation imaging measurement; Participant to undergo conventional ultrasound scanning with attenuation measurement as well.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	all measurements obtained within single 30 minute appointment
Measurement of liver fat using attenuation imaging	Sonographer uses attenuation imaging function to measure liver fd	all measurements obtained within single 30 minute appointment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age of patient	Age of patient	all measurements obtained within single 30 minute appointment
Height	Height, patients height measured immediately after scan.	all measurements obtained within single 30 minute appointment
Weight	Weight, patient weighed immediately after scan	all measurements obtained within single 30 minute appointment
Diagnosis or Relevant history	Diagnosis or relevant history from referral form.	all measurements obtained within single 30 minute appointment

Collaborators and Investigators

• Sponsor: Hywel Dda Health Board

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Actual): April 11, 2024
• Study Completion (Actual): April 11, 2024

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: IRAS 329847

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No