Nonalcoholic SteatohepatitisiLEADNCT04012242
Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study
An observational study of Nonalcoholic Steatohepatitis and Ultrasound, run by Tokyo Medical University at 18 sites in 8 countries.
Trial summary
The objective of this study is: (1) to investigate the correlation of ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, Liver / Kidney Intensity Ratio) with the pathological parameters (fibrosis, intralobular inflammation, ballooning degeneration and steatosis); (2) to… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Nonalcoholic Steatohepatitis, Ultrasound, Elastography
- What is being tested?
- Ultrasound application
- How many people
- 400 participants
- Where
- 18 sitesin 8 countries
- Study dates
- 15 Jun 2019to 31 Jul 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Nonalcoholic fatty liver disease (NAFLD) patients who are scheduled for liver biopsy for the differential diagnosis of NASH and/or NAFLD patients who are scheduled for the MR elastography (MRE) and MRI-proton density fat friction (MRI-PDFF).
Who may be able to join
- Nonalcoholic fatty liver disease (NAFLD) patients who are scheduled for liver biopsy for the differential diagnosis of NASH and/or NAFLD patients who are scheduled for the MR elastography (MRE) and MRI-proton density fat friction (MRI-PDFF).
- Without a history of alcohol use, which lead to alcoholic hepatic involvement (pure alcohol below 30 g/day for male, 20 g/day for female).
Who cannot join
- Patients with endocrine disorder (hypopituitarism, growth hormone deficiency, hyperthyroidism etc.), serious nutrition disorder, and drug-induced hepatic involvement (steroid, tamoxifen, valproic acid, amiodarone etc.), which may lead to the steatosis
- Hepatitis B, Hepatitis C and HIV patients
- Primary biliary cholangitis, Primary sclerosing cholangitis, and Autoimmune hepatitis patients
- Wilson's disease, α1-antitrypsin deficiency, and hemochromatosis patients
- Malignant liver tumor, common bile duct stone, and jaundice patients
- Patients after jejunoileal bypass surgery or massive intestinal resection surgery
- Patients whose treatment changes during the period between imaging examination and liver biopsy, including medications such as antidiabetic drugs and other treatments which may change the fat deposition or inflammation of liver.
Trial locations and contacts
18 sites in 8 countries.
18 sites in 8 countries
United States5 sites, 5 recruiting
- Recruiting
The Surgical Hospital at Southwoods
Boardman, Ohio, 44512
Richard BARR
- Recruiting
Northwestern University
Evanston, Illinois, 60208
Thomas GRANT
- Recruiting
University of Southern California
Los Angeles, California, 90007
Edward GRANT
- Recruiting
Rocky Vista University
Parker, Colorado, 80134
Jing GAO
- Recruiting
University of Washington
Seattle, Washington, 98195
Ted DUBINSKY
China3 sites, 3 recruiting
- Recruiting
SunYatSen University First Hospital
Guangzhou
Xiaoyan XIE
- Recruiting
SunYatSen University Third Hospital
Guangzhou
Rongqin ZHENG
- Recruiting
Zhejiang University No. 2 Hospital
Hangzhou
Pintong HUANG
Germany2 sites, 2 recruiting
- Recruiting
University of Erlangen
Erlangen
Deike STROBEL
- Recruiting
University of Leipzig
Leipzig
Thomas KARLAS
Italy2 sites, 2 recruiting
- Recruiting
University of Pavia
Pavia
Giovanna FERRAIOLI
- Recruiting
Policlinico Umberto I, Univ. La Sapienza
Rome
Vito CANTISANI
Japan2 sites, 2 recruiting
- Recruiting
Hyogo Medical University
Hyōgo
Hiroko Iijima, MD, PhD
- Recruiting
Kurume University
Kurume
Hirohisa Yano, MD, PhD
South Korea2 sites, 2 recruiting
- Recruiting
Chung-Ang University Hospital
Seoul
Byung Ihn CHOI
- Recruiting
Seoul National University Hospital
Seoul
Jae Young LEE
France1 site, 1 recruiting
- Not yet recruiting
University Paris Nord
Paris
Valerie VILGRAIN
United Kingdom1 site, 1 recruiting
- Recruiting
Charing Cross Hospital / Imperial College London
London
Adrian LIM
About this study
Official title: Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study for Patients With Nonalcoholic Steatohepatitis
The objective of this study is: (1) to investigate the correlation of ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, Liver / Kidney Intensity Ratio) with the pathological parameters (fibrosis, intralobular inflammation, ballooning degeneration and steatosis); (2) to evaluate the diagnostic performance of SW speed for liver fibrosis, Dispersion slope for intralobular inflammation and Attenuation value for steatosis by comparison with the tissue diagnosis by liver biopsy.
- Conditions
- Nonalcoholic Steatohepatitis, Ultrasound, Elastography
- Being tested
- Ultrasound application
- Keywords
- Nonalcoholic Steatohepatitis, Ultrasound, Elastography, Dispersion
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound applicationDiagnostic test
Shear wave elastography, shear wave dispersion, attenuation imaging, and intensity analysis
| Study group | Role | What they receive |
|---|---|---|
| NAFLD patients who are scheduled for liver biopsy | Not described Receives: Diagnostic Test: Ultrasound application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23)
Measured: At the time of examination
Secondary outcomes (11)
Correlation between ultrasound parameters and the pathological parameters
Measured: At the time of examination
Diagnostic performance of SW speed for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4).
Measured: At the time of examination
Diagnostic performance of Normalized Local Variance for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4)
Measured: At the time of examination
Diagnostic performance of Normalized Local Variance for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3)
Measured: At the time of examination
Diagnostic performance of Dispersion slope for intralobular inflammation (A0 vs. A123, and A012 vs. A3)
Measured: At the time of examination
Diagnostic performance of Attenuation value for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3)
Measured: At the time of examination
Diagnostic performance of Liver/Kidney Intensity Ratio for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3)
Measured: At the time of examination
Diagnostic performance of the computer aided algorithm for NASH
Measured: At the time of examination
Diagnostic performance of MRI-PDFF for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3).
Measured: At the time of examination
Diagnostic performance of CAP for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3).
Measured: At the time of examination
Diagnostic performance of MRE for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4).
Measured: At the time of examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start15 Jun 2019
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic SteatohepatitisStudies 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
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokyo Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katsutoshi Sugimoto, Tokyo Medical University
- Investigators
- Katsutoshi Sugimoto, MD, PhD, Principal investigator, Tokyo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012242
- Sponsor's protocol ID
- TokyoMU
- Acronym
- iLEAD
- Status last verified
- Feb 2022
- First submitted
- 27 Jun 2019
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sugimoto K, Moriyasu F, Dioguardi Burgio M, Vilgrain V, Jesper D, Strobel D, Blank V, Karlas T, Grant EG, Kelahan LC, Gabriel H, Choi BI, Nishimura T, Iijima H, Dubinsky TJ, Gao J, Lee DH, Lee JY, Zhao Y, Huang P, Zeng J, Lim A, Xie X, Barr RG, Cantisani V, Sakamaki K, Itoi T, Kage M, Yano H. US Markers in the Noninvasive Assessment of Hepatic Steatosis in Metabolic Dysfunction-associated Steatotic Liver Disease. Radiology. 2026 Oct;321(1):e260360. doi: 10.1148/radiol.260360.
PubMed 42937537Sugimoto K, Moriyasu F, Dioguardi Burgio M, Vilgrain V, Jesper D, Strobel D, Blank V, Karlas T, Grant EG, Kelahan LC, Gabriel H, Choi BI, Nishimura T, Iijima H, Dubinsky TJ, Gao J, Lee DH, Lee JY, Zhao Y, Huang P, Zeng J, Lim A, Xie X, Barr RG, Cantisani V, Ferraioli G, Sakamaki K, Itoi T, Kage M, Yano H. US Markers and Necroinflammation, Steatosis, and Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease: The iLEAD Study. Radiology. 2024 Aug;312(2):e233377. doi: 10.1148/radiol.233377.
PubMed 39162633
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study for Patients With Nonalcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT04012242
- Acronym / sponsor ID
- iLEAD / TokyoMU
- Conditions
- Nonalcoholic Steatohepatitis, Ultrasound, Elastography
- Keywords
- Nonalcoholic Steatohepatitis, Ultrasound, Elastography, Dispersion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tokyo Medical UniversityUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 9 Jul 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 objective of this study is: (1) to investigate the correlation of ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, Liver / Kidney Intensity Ratio) with the pathological parameters (fibrosis, intralobular inflammation, ballooning degeneration and steatosis); (2) to evaluate the diagnostic performance of SW speed for liver fibrosis, Dispersion slope for intralobular inflammation and Attenuation value for steatosis by comparison with the tissue diagnosis by liver biopsy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAFLD patients who are scheduled for liver biopsy | – | Diagnostic Test: Ultrasound application |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nonalcoholic fatty liver disease (NAFLD) patients who are scheduled for liver biopsy for the differential diagnosis of NASH and/or NAFLD patients who are scheduled for the MR elastography (MRE) and MRI-proton density fat friction (MRI-PDFF).
Key inclusion criteria (2 listed)
- Nonalcoholic fatty liver disease (NAFLD) patients who are scheduled for liver biopsy for the differential diagnosis of NASH and/or NAFLD patients who are scheduled for the MR elastography (MRE) and MRI-proton density fat friction (MRI-PDFF).
- Without a history of alcohol use, which lead to alcoholic hepatic involvement (pure alcohol below 30 g/day for male, 20 g/day for female).
Key exclusion criteria (7 listed)
- Patients with endocrine disorder (hypopituitarism, growth hormone deficiency, hyperthyroidism etc.), serious nutrition disorder, and drug-induced hepatic involvement (steroid, tamoxifen, valproic acid, amiodarone etc.), which may lead to the steatosis
- Hepatitis B, Hepatitis C and HIV patients
- Primary biliary cholangitis, Primary sclerosing cholangitis, and Autoimmune hepatitis patients
- Wilson's disease, α1-antitrypsin deficiency, and hemochromatosis patients
- Malignant liver tumor, common bile duct stone, and jaundice patients
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 |
|---|---|---|
| Ultrasound applicationShear wave elastography, shear wave dispersion, attenuation imaging, and intensity analysis | Diagnostic test | NAFLD patients who are scheduled for liver biopsy |
Primary outcome
Diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23)
Time frame: At the time of examination
11 secondary outcomes
Correlation between ultrasound parameters and the pathological parameters
Time frame: At the time of examination
Diagnostic performance of SW speed for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4).
Time frame: At the time of examination
Diagnostic performance of Normalized Local Variance for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4)
Time frame: At the time of examination
Diagnostic performance of Normalized Local Variance for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3)
Time frame: At the time of examination
Diagnostic performance of Dispersion slope for intralobular inflammation (A0 vs. A123, and A012 vs. A3)
Time frame: At the time of examination
Diagnostic performance of Attenuation value for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3)
Time frame: At the time of examination
Diagnostic performance of Liver/Kidney Intensity Ratio for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3)
Time frame: At the time of examination
Diagnostic performance of the computer aided algorithm for NASH
Time frame: At the time of examination
Diagnostic performance of MRI-PDFF for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3).
Time frame: At the time of examination
Diagnostic performance of CAP for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3).
Time frame: At the time of examination
Diagnostic performance of MRE for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4).
Time frame: At the time of examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Derived from this study: PubMed 42937537Sugimoto K, Moriyasu F, Dioguardi Burgio M, Vilgrain V, Jesper D, Strobel D, Blank V, Karlas T, Grant EG, Kelahan LC, Gabriel H, Choi BI, Nishimura T, Iijima H, Dubinsky TJ, Gao J, Lee DH, Lee JY, Zhao Y, Huang P, Zeng J, Lim A, Xie X, Barr RG, Cantisani V, Sakamaki K, Itoi T, Kage M, Yano H. US Markers in the Noninvasive Assessment of Hepatic Steatosis in Metabolic Dysfunction-associated Steatotic Liver Disease. Radiology. 2026 Oct;321(1):e260360. doi: 10.1148/radiol.260360.
- Derived from this study: PubMed 39162633Sugimoto K, Moriyasu F, Dioguardi Burgio M, Vilgrain V, Jesper D, Strobel D, Blank V, Karlas T, Grant EG, Kelahan LC, Gabriel H, Choi BI, Nishimura T, Iijima H, Dubinsky TJ, Gao J, Lee DH, Lee JY, Zhao Y, Huang P, Zeng J, Lim A, Xie X, Barr RG, Cantisani V, Ferraioli G, Sakamaki K, Itoi T, Kage M, Yano H. US Markers and Necroinflammation, Steatosis, and Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease: The iLEAD Study. Radiology. 2024 Aug;312(2):e233377. doi: 10.1148/radiol.233377.
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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.
Katsutoshi Sugimoto, MD, PhD principal investigator
Tokyo Medical University
18 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Steatohepatitis and Ultrasound, run by Tokyo Medical University at 18 sites in 8 countries.
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 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: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, China, Germany, Italy, Japan and 3 more countries. 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?
Contact Fuminori Moriyasu, MD, PhD (+81-3-3402-3151, moriyasy@iuhw.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23) (time frame: At the time of examination). 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 NCT04012242, which also lists 2 linked publications.
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 8 Feb 2022.