Fatty LiverNCT05855239
Quantification of Hepatic Steatosis With Different Ultrasound Frequency
An observational study of Fatty Liver and Fatty Liver, Nonalcoholic, run by Jong Keon Jang at 1 site in South Korea.
Trial summary
The objective of this study is: (1) to compare the feasibility (technical successes rate and reliability) in measuring attenuation coefficient between two different frequencies (3MHz, 4MHz) of ultrasound beam; (2) to evaluate and compare the diagnostic performance of attenuation coefficient for steatosis using two… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatty Liver, Fatty Liver, Nonalcoholic, Ultrasound
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jun 2023to 31 Dec 2024
- How long will I take part?
- 3 Months
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants at risk of fatty liver disease
Who may be able to join
- Participants who are candidates for liver donation and scheduled liver biopsies for assessment of hepatic steatosis
- Participants suspected of nonalcoholic fatty liver disease and scheduled for liver biopsy or surgery
Who cannot join
- Participants with a BMI of less than 23
- Participants underwent liver transplantation or right hepatectomy
- Participants who have a large mass in the right liver
- Participants who have a bleeding tendency (platelet count < 80000, prothrombin time and international normalized ratio > 1.5)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of Hepatic Steatosis in Patients With Fatty Liver Disease Using Attenuation Imaging With Different Ultrasound Frequency
The objective of this study is: (1) to compare the feasibility (technical successes rate and reliability) in measuring attenuation coefficient between two different frequencies (3MHz, 4MHz) of ultrasound beam; (2) to evaluate and compare the diagnostic performance of attenuation coefficient for steatosis using two different frequencies (3MHz, 4MHz) of ultrasound beam by comparison with the pathologic results acquired by liver biopsy or surgery.
Read the detailed description
Investigators measure the distance between the skin and liver capsule on B-mod images.
Investigators place a region of interest (ROI) avoiding reverberation artifacts and acquire attenuation coefficient for five times.
For participants who require a liver biopsy, investigators try to target the same area in the liver, where ROI was placed.
Investigators evaluate hepatic steatosis, lobular inflammation, and fibrosis of tissue of the liver using a scoring system suggested by Nonalcoholic Steatohepatitis Clinical Research Network.
- Conditions
- Fatty Liver, Fatty Liver, Nonalcoholic, Ultrasound
- Keywords
- Hepatic steatosis, Quantification, Ultrasound, Attenuation coefficient
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Attenuation coefficient (3MHz vs. 4MHz) in attenuating imaging
dB/cm/MHz
Measured: During procedure
Percentage of fat within hepatocyte in pathological specimen
S0 (<5%), S1(5%~33%), S2(34%~66%), and S3 (>66%)
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start8 Jun 2023
- Primary completion30 Jun 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies 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
- 120 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Jong Keon Jang
- Sponsor type
- University, hospital or other
- Collaborators
- Canon Medical Systems, Korea
- Responsible party
- Sponsor-investigator, Jong Keon Jang, Asan Medical Center
- Investigators
- JongKeon Jang, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855239
- Sponsor's protocol ID
- ATI_Freq_01
- Status last verified
- Aug 2024
- First submitted
- 29 Apr 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data with another researcher
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Hepatic Steatosis in Patients With Fatty Liver Disease Using Attenuation Imaging With Different Ultrasound Frequency
- ClinicalTrials.gov ID
- NCT05855239
- Acronym / sponsor ID
- ATI_Freq_01
- Conditions
- Fatty Liver, Fatty Liver, Nonalcoholic, Ultrasound
- Keywords
- Hepatic steatosis, Quantification, Ultrasound, Attenuation coefficient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jong Keon JangUniversity, hospital or other
- Collaborators
- Canon Medical Systems, Korea
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 May 2023 (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 objective of this study is: (1) to compare the feasibility (technical successes rate and reliability) in measuring attenuation coefficient between two different frequencies (3MHz, 4MHz) of ultrasound beam; (2) to evaluate and compare the diagnostic performance of attenuation coefficient for steatosis using two different frequencies (3MHz, 4MHz) of ultrasound beam by comparison with the pathologic results acquired by liver biopsy or surgery.
Detailed description
Investigators measure the distance between the skin and liver capsule on B-mod images.
Investigators place a region of interest (ROI) avoiding reverberation artifacts and acquire attenuation coefficient for five times.
For participants who require a liver biopsy, investigators try to target the same area in the liver, where ROI was placed.
Investigators evaluate hepatic steatosis, lobular inflammation, and fibrosis of tissue of the liver using a scoring system suggested by Nonalcoholic Steatohepatitis Clinical Research Network.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants at risk of fatty liver disease
Key inclusion criteria (2 listed)
- Participants who are candidates for liver donation and scheduled liver biopsies for assessment of hepatic steatosis
- Participants suspected of nonalcoholic fatty liver disease and scheduled for liver biopsy or surgery
Key exclusion criteria (4 listed)
- Participants with a BMI of less than 23
- Participants underwent liver transplantation or right hepatectomy
- Participants who have a large mass in the right liver
- Participants who have a bleeding tendency (platelet count < 80000, prothrombin time and international normalized ratio > 1.5)
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
Attenuation coefficient (3MHz vs. 4MHz) in attenuating imaging
Time frame: During procedure
dB/cm/MHz
Percentage of fat within hepatocyte in pathological specimen
Time frame: During procedure
S0 (<5%), S1(5%~33%), S2(34%~66%), and S3 (>66%)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No. No plan to share data with another researcher
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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.
JongKeon Jang, Professor principal investigator
Asan Medical Center
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 Fatty Liver and Fatty Liver, Nonalcoholic, run by Jong Keon Jang at 1 site in South Korea.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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 South Korea. 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?
Results are not available in the source record.
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?
Attenuation coefficient (3MHz vs. 4MHz) in attenuating imaging (time frame: During procedure). The study lists 2 primary outcomes in all. 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 6 Aug 2024.