Fatty LiverNCT04462562
Quantitative US for Evaluation of Hepatic Steatosis in NAFLD
A study testing Quantitative US (Samsung Medison, RS85A) in people with Fatty Liver and Fatty Liver, Nonalcoholic, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate diagnostic performance of quantitative ultrasonographic parameters for the assessment of hepatic steatosis with find optimal cut-off values in patients with non-alcoholic fatty liver disease using magnetic resonance imaging proton density fat fraction (MRI-PDFF) and MR… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatty Liver, Fatty Liver, Nonalcoholic
- What is being tested?
- Quantitative US (Samsung Medison, RS85A)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jul 2020to 29 Jun 2021
- 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 known NAFLD or suspected of having NAFLD
- Patients who are scheduled hepatectomy for living donor liver donation
- aged ≥ 18 years who are willing and able to complete all procedures
Who cannot join
- excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women)
- clinical, laboratory, or histologic evidence of a liver disease other than NAFLD, including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders
- use of steatogenic or hepatotoxic medication
- evidence of decompensated liver disease
- history of liver surgery
- contraindication to MRI
- any other condition believed by investigator to affect a patients' compliance, or completion of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Diagnostic Performance Assessment of Quantitative Ultrasound Imaging Indices for Differentiating Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease
The purpose of this study is to evaluate diagnostic performance of quantitative ultrasonographic parameters for the assessment of hepatic steatosis with find optimal cut-off values 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
- Fatty Liver, Fatty Liver, Nonalcoholic
- Being tested
- Quantitative US (Samsung Medison, RS85A)
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative US (Samsung Medison, RS85A)Diagnostic test
In each patients, measurements of tissue attenuation imagine (TAI), tissue scatter-distribution imaging (TSI) parameters, hepatorenal index (EzHRI) will be performed
| Study group | Role | What they receive |
|---|---|---|
| quantitative ultrasound imaging parameters | Experimental | quantitative ultrasound imaging parameters
* tissue attenuation imaging (TAI) parameter
* tissue scatter-distribution imaging (TSI) parameter
* Hepatorenal index (semi-auto, EzHRI) Receives: Diagnostic Test: Quantitative US (Samsung Medison, RS85A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent)
Reference standard: MRI-proton density fat fraction or MR spectroscopy value (5 percent)
- ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF >5 percent patients
Measured: 1 month
Secondary outcomes (6)
Diagnostic performance (area under the ROC curve (AUC)) of QUS parameters (TAI, TSI) for detection of moderate fatty liver (MRI-PDFF 10, 20 percent)
Reference standard: MRI-PDFF or MR spectroscopy value (10 percent, 15 percent, 15 percent, 20 percent, 25 percent)
- ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF >10, >20 percent patients
Measured: 1 month
Correlation of QUS parameters and MR fat fraction
reference standard: MRI-PDFF or MR spectroscopy value (percent)
- spearman's rank correlation of QUS parameters (TAI, TSI) values with MR fat fraction(percent)
Measured: 1 month
Intra-observer agreement of quantitative US parameters
Intraclass correlation coefficient (ICC), coefficient of variation (CV) of QUS parameter values (TAI value, TSI value)
Measured: 1 day
Correlation between estimated fat fraction from deep learning model and MRI-proton density fat fraction
pearson correlation coefficient (r) between estimated fat fraction and MRI-proton density fat fraction
Measured: 1 month
Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (10 percent, 15 percent, 15 percent, 20 percent)
Reference standard: MRI-proton density fat fraction (10 percent, 15 percent, 20 percent, 20 percent)
Measured: 1 month
Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (5 percent)
Reference standard: MRI-proton density fat fraction (5 percent)
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 posted8 Jul 2020
- Study start3 Jul 2020
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
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 Fatty LiverStudies 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
- 173 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
- Jeong Min Lee, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462562
- Sponsor's protocol ID
- SNUH 2002-020-1099
- Status last verified
- Mar 2022
- First submitted
- 31 Mar 2020
- Last updated
- 18 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Performance Assessment of Quantitative Ultrasound Imaging Indices for Differentiating Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04462562
- Acronym / sponsor ID
- SNUH 2002-020-1099
- Conditions
- Fatty Liver, Fatty Liver, Nonalcoholic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Samsung Medison
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 8 Jul 2020 (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 evaluate diagnostic performance of quantitative ultrasonographic parameters for the assessment of hepatic steatosis with find optimal cut-off values 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 parameters | Experimental | Diagnostic Test: Quantitative US (Samsung Medison, RS85A)quantitative ultrasound imaging parameters * tissue attenuation imaging (TAI) parameter * tissue scatter-distribution imaging (TSI) parameter * Hepatorenal index (semi-auto, EzHRI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with known NAFLD or suspected of having NAFLD
- Patients who are scheduled hepatectomy for living donor liver donation
- aged ≥ 18 years who are willing and able to complete all procedures
Key exclusion criteria (7 listed)
- excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women)
- clinical, laboratory, or histologic evidence of a liver disease other than NAFLD, including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders
- use of steatogenic or hepatotoxic medication
- evidence of decompensated liver disease
- history of liver surgery
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 US (Samsung Medison, RS85A)In each patients, measurements of tissue attenuation imagine (TAI), tissue scatter-distribution imaging (TSI) parameters, hepatorenal index (EzHRI) will be performed | Diagnostic test | quantitative ultrasound imaging parameters |
Primary outcome
Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent)
Time frame: 1 month
Reference standard: MRI-proton density fat fraction or MR spectroscopy value (5 percent) - ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF >5 percent patients
6 secondary outcomes
Diagnostic performance (area under the ROC curve (AUC)) of QUS parameters (TAI, TSI) for detection of moderate fatty liver (MRI-PDFF 10, 20 percent)
Time frame: 1 month
Correlation of QUS parameters and MR fat fraction
Time frame: 1 month
Intra-observer agreement of quantitative US parameters
Time frame: 1 day
Correlation between estimated fat fraction from deep learning model and MRI-proton density fat fraction
Time frame: 1 month
Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (10 percent, 15 percent, 15 percent, 20 percent)
Time frame: 1 month
Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (5 percent)
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 18 Mar 2022.
- 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.
Related trials for Fatty Liver
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
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.
Jeong 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 US (Samsung Medison, RS85A) in people with Fatty Liver and Fatty Liver, Nonalcoholic, 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 3 inclusion and 7 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 18 Mar 2022. 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?
Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent) (time frame: 1 month). 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 NCT04462562, 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 18 Mar 2022.