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OpenTrials
Completed

NCT Number: NCT07616843

STANDARDIZATION OF THE PROTOCOL FOR ATTENUATION COEFFICIENT MEASUREMENT

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: up to 3 years

    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

Secondary outcomes

  1. 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

    Time frame: up to 3 years

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

    Time frame: up to 3 years

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

    Time frame: up to 3 years

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

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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