Hepatic SteatosisNCT04180631
Quantitative US for Hepatic Steatosis
A study testing Quantitative ultrasound imaging parameter (QUS) in people with Hepatic Steatosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the diagnostic performance of quantitative ultrasound imaging parameter for the assessment of hepatic steatosis in patients with non-alcoholic fatty liver disease using magnetic resonance imaging proton density fat fraction (MRI-PDFF) and MR spectroscopy as the reference… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Steatosis
- What is being tested?
- Quantitative ultrasound imaging parameter (QUS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Mar 2019to 19 Jan 2020
- Phase
- Interventional
- 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
Who may be able to join
- patients with clinically suspected non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), or living-donor candidates for liver transplantation, or volunteers
- Signed informed consent
Who cannot join
- chronic liver disease patients (serum HBsAg positive or anti-hepatitis C virus (HCV), histologic confirmation)
- chronic alcoholics
- serum alanine transaminase (ALT)>5 times the upper limit of normal within 3 months
- previous liver surgery
- acute hepatitis or bile duct obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Value of Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease
The purpose of this study is to investigate the diagnostic performance of quantitative ultrasound imaging parameter for the assessment of hepatic steatosis in patients with non-alcoholic fatty liver disease using magnetic resonance imaging proton density fat fraction (MRI-PDFF) and MR spectroscopy as the reference standard.
- Conditions
- Hepatic Steatosis
- Being tested
- Quantitative ultrasound imaging parameter (QUS)
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative ultrasound imaging parameter (QUS)Diagnostic test
Quantitative ultrasound imaging parameters (QUS) are analyzed to evaluate hepatic steatosis
| Study group | Role | What they receive |
|---|---|---|
| Quantitative ultrasound imaging parameter | Experimental | Quantitative ultrasound imaging parameter (QUS) Receives: Diagnostic Test: Quantitative ultrasound imaging parameter (QUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between quantitative US imaging parameter (QUS) and MR fat fraction
reference standard: MR spectroscopy or MRI-proton density fat fraction value
Measured: 3 months
Secondary outcomes (4)
Diagnostic performance of QUS to detect mild fatty liver and moderate fatty liver
reference standard: MR fat fraction
Measured: 3 months
Correlation between S-shearwave elastography and MR elastography
Reference standard: liver stiffness at MR elastography, using Pearson's correlation analysis or Spearman rank correlation analysis
Measured: 3 months
Intra-observer agreement of quantitative ultrasound imaging parameter
intraclass correlation coefficient (ICC)
Measured: same 1 day
Development and validation of deep learning model for prediction of hepatic steatosis
ROC analysis and C-index for deep learning model for prediction of hepatic steatosis
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start5 Mar 2019
- Primary completion19 Jan 2020
- Study completion19 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic SteatosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medison
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeon Min Lee, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180631
- Sponsor's protocol ID
- SNUH-1808-155-967
- Status last verified
- Aug 2021
- First submitted
- 8 Jan 2019
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeon SK, Lee JM, Joo I, Yoon JH, Lee G. Two-dimensional Convolutional Neural Network Using Quantitative US for Noninvasive Assessment of Hepatic Steatosis in NAFLD. Radiology. 2023 Apr;307(1):e221510. doi: 10.1148/radiol.221510. Epub 2023 Jan 3.
PubMed 36594835
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04180631
- Acronym / sponsor ID
- SNUH-1808-155-967
- Conditions
- Hepatic Steatosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Samsung Medison
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 19 Jan 2020 (actual)
- Study completion
- 19 Jan 2020 (actual)
- First posted
- 27 Nov 2019 (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 purpose of this study is to investigate the diagnostic performance of quantitative ultrasound imaging parameter for the assessment of hepatic steatosis in patients with non-alcoholic fatty liver disease using magnetic resonance imaging proton density fat fraction (MRI-PDFF) and MR spectroscopy as the reference standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quantitative ultrasound imaging parameter | Experimental | Diagnostic Test: Quantitative ultrasound imaging parameter (QUS)Quantitative ultrasound imaging parameter (QUS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with clinically suspected non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), or living-donor candidates for liver transplantation, or volunteers
- Signed informed consent
Key exclusion criteria (5 listed)
- chronic liver disease patients (serum HBsAg positive or anti-hepatitis C virus (HCV), histologic confirmation)
- chronic alcoholics
- serum alanine transaminase (ALT)>5 times the upper limit of normal within 3 months
- previous liver surgery
- acute hepatitis or bile duct obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative ultrasound imaging parameter (QUS)Quantitative ultrasound imaging parameters (QUS) are analyzed to evaluate hepatic steatosis | Diagnostic test | Quantitative ultrasound imaging parameter |
Primary outcome
Correlation between quantitative US imaging parameter (QUS) and MR fat fraction
Time frame: 3 months
reference standard: MR spectroscopy or MRI-proton density fat fraction value
4 secondary outcomes
Diagnostic performance of QUS to detect mild fatty liver and moderate fatty liver
Time frame: 3 months
Correlation between S-shearwave elastography and MR elastography
Time frame: 3 months
Intra-observer agreement of quantitative ultrasound imaging parameter
Time frame: same 1 day
Development and validation of deep learning model for prediction of hepatic steatosis
Time frame: 1 month
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 19 Aug 2021.
- Derived from this study: PubMed 36594835Jeon SK, Lee JM, Joo I, Yoon JH, Lee G. Two-dimensional Convolutional Neural Network Using Quantitative US for Noninvasive Assessment of Hepatic Steatosis in NAFLD. Radiology. 2023 Apr;307(1):e221510. doi: 10.1148/radiol.221510. Epub 2023 Jan 3.
- Individual participant dataSharing planned: No
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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.
Jeon Min Lee study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative ultrasound imaging parameter (QUS) in people with Hepatic Steatosis, run by Seoul National University Hospital 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 5 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 19 Aug 2021. 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?
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?
Correlation between quantitative US imaging parameter (QUS) and MR fat fraction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04180631, which also lists 1 linked publication.
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 19 Aug 2021.