STANDARDIZATION OF THE PROTOCOL FOR ATTENUATION COEFFICIENT MEASUREMENT

NCT07616843 | Completed

• 1 other identifier: p_93273
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The assessment of liver fat content is important in patients suspected of or diagnosed with chronic liver disease. Non-alcoholic fatty liver disease (NAFLD) is defined by the presence of hepatic fat content ≥5% of hepatocytes. NAFLD is currently the most common chronic liver disease worldwide with an estimated prevalence of 5-30% in the general population and in 55% up to 80% of patients with type 2 diabetes. New ultrasound methods for a non-invasive and quantitative assessment of the liver fat content have recently been developed. They are based on the estimation of the attenuation coefficient of the ultrasound beam. Our group has conducted studies to evaluate the performance of the attenuation coefficient available on the Aplio i800 ultrasound system (ATI, Canon Medical Systems). The Aplio i800 ultrasound system has already a CE mark, and is available at our Ultrasound Unit for research purposes. ATI has showed a high accuracy for the quantification of liver fat, and was more accurate than the controlled attenuation parameter (CAP, FibroScan) in assessing significant steatosis. The aim of the study is therefore the optimization of the acquisition protocol of ATI measurements on the system Aplio i800, which has already a CE mark.

Conditions

Liver Steatosis

Outcome Measures

Primary Outcomes (1)

• evaluation of the concordance of attenuation coefficient measurements taken with different technical approaches

  Technical parameters considered are the position of the transducer, Breath-hold versus free breathing , Depth dependency, Intercostal approach vs subcostal vs left lobe, Separate acquisition of the attenuation coefficient versus simultaneous acquisition in "QUAD view" mode (stiffness / dispersion / ATI), Measurements of the attenuation coefficient using different ultrasound windows

  up to 3 years

Secondary Outcomes (3)

• evaluation of the different parameters for measuring the attenuation coefficient determinates limits of agreement (LoA) that are larger than a pre-defined maximum allowed difference (Δ) in a Bland and Altman plot

  up to 3 years

• evaluation of the results and whether they are influenced by food intake

  up to 3 years

• evaluation of the results and whether they are influenced by the level of hydration

  up to 3 years

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

Healthy adult volunteers

You may qualify if:

• Informed consent
• Healthy adult volunteers (\> 18 years)
• Ability to suspend respiration for image acquisition

You may not qualify if:

• Pregnancy
• age \< 18 years
• Presence of ascites, acute viral hepatitis, transaminase flares, congestive heart failure, infiltrative diseases.
• No major medical conditions and in particular no known hepatic diseases
• Any other condition that, upon clinical judgment of the investigator, will make unacceptable the study participation for that individual subject
• Consent withdrawal

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo, SSD Malattie Infettive 3 - Ecografia

Pavia, Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: June 1, 2026
• Study Start: January 27, 2022
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: June 1, 2026

Record last verified: 2025-02

Locations

IT (1)