MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT06662851
Usefulness of Ultrasound-derived Fat Fraction for Quantification of Hepatic Steatosis in Patients Suspected of MASLD
An observational study of MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, run by So Yeon Kim at 1 site in South Korea.
Trial summary
This study aims to evaluate the diagnostic utility of ultrasound-derived fat fraction (UDFF) in assessing hepatic steatosis in patients with suspected metabolic dysfunction-associated steatotic liver disease (MASLD). Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- UDFF
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 May 2024to 30 Aug 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suspected of MASLD, who are scheduled for pathologic exam such as liver biopsy or surgery
Who may be able to join
- Patients older than 18 and younger than 80 years
- Patients suspected of MASLD
- Patients who are planned to undergo either liver biopsy or surgery
- Patients willing to provide written informed consent.
Who cannot join
- Patients with a large tumor in Rt. hemiliver causing difficulty in performing UDFF measurement
- Patients with previous liver surgery or transplantation
- Patients with insufficient pathologic specimen for analysis of steatosis and fibrosis grade.
- Any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with completing the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of Ultrasound-derived Fat Fraction for Quantification of Hepatic Steatosis in Patients Suspected of MASLD: a Prospective Study
This study aims to evaluate the diagnostic utility of ultrasound-derived fat fraction (UDFF) in assessing hepatic steatosis in patients with suspected metabolic dysfunction-associated steatotic liver disease (MASLD). Using a prospective, cross-sectional design, the study will compare UDFF results with established diagnostic methods, including liver biopsy, MRI proton density fat fraction (PDFF), and controlled attenuation parameters (CAP) measurements. The ultimate goal is to determine if UDFF can serve as a non-invasive alternative to liver biopsy for diagnosing and staging hepatic steatosis, potentially reducing the need for invasive procedures in MASLD management.
Read the detailed description
This prospective observational study, conducted at a single tertiary institution, will investigate the efficacy of ultrasound-derived fat fraction (UDFF) and point shear wave elastography (p-SWE) as non-invasive methods for quantifying liver fat content and fibrosis in patients scheduled for liver biopsy or surgery. The study will enroll 150 participants, suspected of MASLD and who are candidates for liver biopsy or resection.
The study will utilize Siemens ultrasound equipment to measure the UDFF using attenuation coefficient (AC) and backscatter coefficient (BSC) values for liver fat quantification. Additionally, TE parameters, such as controlled attenuation parameter (CAP) and liver stiffness measurement (LSM), will be recorded for comparison. The primary outcomes will assess UDFF's diagnostic accuracy against liver biopsy and MRI-PDFF. Secondary outcomes will include assessment of intra- and inter-observer variability, and correlations with patients' clinical data, such as BMI, liver fibrosis stages and liver function tests.
Expected benefits include validating UDFF as a reliable, non-invasive alternative for liver fat assessment, potentially reducing the need for invasive biopsies in managing liver disease.
- Being tested
- UDFF
- Keywords
- MASLD, Ultrasound, Steatosis, Liver Diseases, Fibrosis
- Medical subject headings
- Fatty Liver, Liver Diseases, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UDFFDiagnostic test
Ultrasound-Derived Fat Fraction (UDFF) is a quantitative ultrasound technique used to assess hepatic steatosis by measuring the amount of fat in the liver tissue. UDFF estimates fat content using specific ultrasound parameters, namely the attenuation coefficient (AC) and backscatter coefficient (BSC). The AC measures the rate at which ultrasound waves weaken as they pass through the liver, which correlates with fat content, while the BSC quantifies the amount of reflected ultrasound signal, providing additional insights into liver tissue characteristics.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation and agreement between UDFF and PDFF
Spearman rank correlation coefficient Intraclass correlation coefficient (ICC) with a 2-way random effects model for absolute agreement Bland-Altman plots
Measured: During procedure
Diagnostic performance of UDFF for detecting and grading steatosis based on PDFF and histologic reference
AUROC analysis
Measured: During procedure
Secondary outcomes (2)
Intra-observer and inter-observer agreement
Intraclass correlation coefficient
Measured: During procedure
UDFF performance in different fibrosis stages
Subgroup analysis according to different fibrosis stages
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 posted29 Oct 2024
- Study start27 May 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- So Yeon Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, So Yeon Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662851
- Sponsor's protocol ID
- ASANMC_UDFF
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Ultrasound-derived Fat Fraction for Quantification of Hepatic Steatosis in Patients Suspected of MASLD: a Prospective Study
- ClinicalTrials.gov ID
- NCT06662851
- Acronym / sponsor ID
- ASANMC_UDFF
- Keywords
- MASLD, Ultrasound, Steatosis, Liver Diseases, Fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- So Yeon KimUniversity, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 29 Oct 2024 (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.
This study aims to evaluate the diagnostic utility of ultrasound-derived fat fraction (UDFF) in assessing hepatic steatosis in patients with suspected metabolic dysfunction-associated steatotic liver disease (MASLD). Using a prospective, cross-sectional design, the study will compare UDFF results with established diagnostic methods, including liver biopsy, MRI proton density fat fraction (PDFF), and controlled attenuation parameters (CAP) measurements. The ultimate goal is to determine if UDFF can serve as a non-invasive alternative to liver biopsy for diagnosing and staging hepatic steatosis, potentially reducing the need for invasive procedures in MASLD management.
Detailed description
This prospective observational study, conducted at a single tertiary institution, will investigate the efficacy of ultrasound-derived fat fraction (UDFF) and point shear wave elastography (p-SWE) as non-invasive methods for quantifying liver fat content and fibrosis in patients scheduled for liver biopsy or surgery. The study will enroll 150 participants, suspected of MASLD and who are candidates for liver biopsy or resection.
The study will utilize Siemens ultrasound equipment to measure the UDFF using attenuation coefficient (AC) and backscatter coefficient (BSC) values for liver fat quantification. Additionally, TE parameters, such as controlled attenuation parameter (CAP) and liver stiffness measurement (LSM), will be recorded for comparison. The primary outcomes will assess UDFF's diagnostic accuracy against liver biopsy and MRI-PDFF. Secondary outcomes will include assessment of intra- and inter-observer variability, and correlations with patients' clinical data, such as BMI, liver fibrosis stages and liver function tests.
Expected benefits include validating UDFF as a reliable, non-invasive alternative for liver fat assessment, potentially reducing the need for invasive biopsies in managing liver disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspected of MASLD, who are scheduled for pathologic exam such as liver biopsy or surgery
Key inclusion criteria (4 listed)
- Patients older than 18 and younger than 80 years
- Patients suspected of MASLD
- Patients who are planned to undergo either liver biopsy or surgery
- Patients willing to provide written informed consent.
Key exclusion criteria (4 listed)
- Patients with a large tumor in Rt. hemiliver causing difficulty in performing UDFF measurement
- Patients with previous liver surgery or transplantation
- Patients with insufficient pathologic specimen for analysis of steatosis and fibrosis grade.
- Any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with completing the study.
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 |
|---|---|---|
| UDFFUltrasound-Derived Fat Fraction (UDFF) is a quantitative ultrasound technique used to assess hepatic steatosis by measuring the amount of fat in the liver tissue. UDFF estimates fat content using specific ultrasound parameters, namely the attenuation coefficient (AC) and backscatter coefficient (BSC). The AC measures the rate at which ultrasound waves weaken as they pass through the liver, which correlates with fat content, while the BSC quantifies the amount of reflected ultrasound signal, providing additional insights into liver tissue characteristics. | Diagnostic test | – |
Primary outcome
Correlation and agreement between UDFF and PDFF
Time frame: During procedure
Spearman rank correlation coefficient Intraclass correlation coefficient (ICC) with a 2-way random effects model for absolute agreement Bland-Altman plots
Diagnostic performance of UDFF for detecting and grading steatosis based on PDFF and histologic reference
Time frame: During procedure
AUROC analysis
2 secondary outcomes
Intra-observer and inter-observer agreement
Time frame: During procedure
UDFF performance in different fibrosis stages
Time frame: During procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- 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.
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 MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, run by So Yeon Kim 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 4 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 29 Oct 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?
Correlation and agreement between UDFF and PDFF (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 29 Oct 2024.