Diagnoses DiseaseNCT04985188
Quantitative Ultrasound for Diagnosing Hepatic Steatosis in Nonalcoholic Fatty Liver Multicenter Study
An observational study of Diagnoses Disease, run by Seoul National University Hospital.
Trial summary
To evaluate the diagnostic performance of quantitative ultrasound parameters for assessing hepatic steatosis in non-alcoholic fatty liver disease using histologic results as reference standard Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnoses Disease
- What is being tested?
- Quantitative ultrasound (QUS) technique
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 12 Aug 2021to 31 Dec 2022
- 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
- Adult, Older adult
Study population: Clinically suspected or proven nonalcoholic fatty liver disease (NAFLD)
Who may be able to join
- Clinically suspected or proven nonalcoholic fatty liver disease (NAFLD)
- Patients who are scheduled hepatic parenchymal biopsy for suspected liver disease or 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
- any other condition believed by investigator to affect a patients' compliance, or completion of the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease: Multicenter Prospective Study
To evaluate the diagnostic performance of quantitative ultrasound parameters for assessing hepatic steatosis in non-alcoholic fatty liver disease using histologic results as reference standard
- Conditions
- Diagnoses Disease
- Being tested
- Quantitative ultrasound (QUS) technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative ultrasound (QUS) techniqueDiagnostic test
Measurement of quantitative ultrasound parameter using clinical US machine (RS85)
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S1)
Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S1)(reference standard: pathologic result)
Measured: 1 month
Secondary outcomes (2)
Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S2 and S3)
Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S2 and S3)(reference standard: pathologic result)
Measured: 1 month
Diagnostic performance of quantitative ultrasound parameters for diagnosing nonalcoholic steatohepatitis (NASH)
Evaluation of area under the ROC curve (AUC) for the detection of nonalcoholic steatohepatitis (reference standard: pathologic result)
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 posted2 Aug 2021
- Study start12 Aug 2021 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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 Diagnoses DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Ruijin Hospital, Shenzhen Second People's Hospital, Samsung Medison
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985188
- Sponsor's protocol ID
- 2102-159-1199
- Status last verified
- Jul 2021
- First submitted
- 26 Jul 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang TY, Li ZY, Tian J, Xie XJ, Lee JM, Ren XP, Xie XY. Metabolic Dysfunction-Associated Steatotic Liver Disease at Quantitative US: International Prospective Study. Radiology. 2025 Jul;316(1):e242564. doi: 10.1148/radiol.242564.
PubMed 40662970
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease: Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT04985188
- Acronym / sponsor ID
- 2102-159-1199
- Conditions
- Diagnoses Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Ruijin Hospital, Shenzhen Second People's Hospital, Samsung Medison
- Study start
- 12 Aug 2021 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Aug 2021 (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.
To evaluate the diagnostic performance of quantitative ultrasound parameters for assessing hepatic steatosis in non-alcoholic fatty liver disease using histologic results as reference standard
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Clinically suspected or proven nonalcoholic fatty liver disease (NAFLD)
Key inclusion criteria (3 listed)
- Clinically suspected or proven nonalcoholic fatty liver disease (NAFLD)
- Patients who are scheduled hepatic parenchymal biopsy for suspected liver disease or hepatectomy for living donor liver donation
- aged ≥ 18 years who are willing and able to complete all procedures
Key exclusion criteria (6 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 ultrasound (QUS) techniqueMeasurement of quantitative ultrasound parameter using clinical US machine (RS85) | Diagnostic test | – |
Primary outcome
Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S1)
Time frame: 1 month
Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S1)(reference standard: pathologic result)
2 secondary outcomes
Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S2 and S3)
Time frame: 1 month
Diagnostic performance of quantitative ultrasound parameters for diagnosing nonalcoholic steatohepatitis (NASH)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Derived from this study: PubMed 40662970Huang TY, Li ZY, Tian J, Xie XJ, Lee JM, Ren XP, Xie XY. Metabolic Dysfunction-Associated Steatotic Liver Disease at Quantitative US: International Prospective Study. Radiology. 2025 Jul;316(1):e242564. doi: 10.1148/radiol.242564.
- Individual participant dataSharing planned: Undecided
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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.
Jeong Min Lee, MD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnoses Disease, run by Seoul National University Hospital.
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: status not confirmed, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jeong Min Lee, MD (02-2072-3107, jmlshy2000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S1) (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 NCT04985188, 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 2 Aug 2021.