Ultrasound and Attenuation Imaging

NCT06552377 | Completed FDA Device

• 1 other identifier: IRAS 329847
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Non-Alcoholic Fatty Liver Disease; Non Alcoholic Fatty Liver; Non-alcoholic Steatohepatitis; Steatosis of Liver

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Age of patient

  all measurements obtained within single 30 minute appointment

• Height

  all measurements obtained within single 30 minute appointment

• Weight

  all measurements obtained within single 30 minute appointment

• Diagnosis or Relevant history

  all measurements obtained within single 30 minute appointment

Study Arms (1)

All participants

Ultrasound attenuation imaging measurement

Device: Ultrasound Attenuation imaging measurement

Interventions

Ultrasound Attenuation imaging measurement DEVICE

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

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hywel Dda Health Board: lead

Study Sites (1)

Bronglais Hospital

Aberystwyth, Ceredigion, SY23 1ER, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 14, 2024
• Study Start: February 14, 2024
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)