Liver SteatosisNCT07616843
STANDARDIZATION OF THE PROTOCOL FOR ATTENUATION COEFFICIENT MEASUREMENT
An observational study of Liver Steatosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Steatosis
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jan 2022to 5 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers
Who may be able to join
- Informed consent
- Healthy adult volunteers (> 18 years)
- Ability to suspend respiration for image acquisition
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo, SSD Malattie Infettive 3 - Ecografia
Pavia, Pavia, 27100
About this study
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
- Medical subject headings
- Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 3 years
evaluation of the results and whether they are influenced by food intake
Measured: up to 3 years
evaluation of the results and whether they are influenced by the level of hydration
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start27 Jan 2022
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver SteatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluigi Poma, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616843
- Sponsor's protocol ID
- p_93273
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STANDARDIZATION OF THE PROTOCOL FOR ATTENUATION COEFFICIENT MEASUREMENT
- ClinicalTrials.gov ID
- NCT07616843
- Acronym / sponsor ID
- p_93273
- Conditions
- Liver Steatosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers
Key inclusion criteria (3 listed)
- Informed consent
- Healthy adult volunteers (> 18 years)
- Ability to suspend respiration for image acquisition
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
evaluation of the results and whether they are influenced by food intake
Time frame: up to 3 years
evaluation of the results and whether they are influenced by the level of hydration
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Steatosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of the concordance of attenuation coefficient measurements taken with different technical approaches (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.