Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552377
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Ultrasound and Attenuation Imaging
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Cross-sectional Study Assessing the Agreement Between Sonographer Based Assessment of the Fatty Liver Using Conventional Ultrasound and Attenuation Imaging Scoring
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None