NCT04012242

Brief 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 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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
8 countries

18 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

3.1 years

First QC Date

June 27, 2019

Last Update Submit

February 6, 2022

Conditions

Nonalcoholic SteatohepatitisUltrasoundElastography

Keywords

Nonalcoholic SteatohepatitisUltrasoundElastographyDispersion

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23)

    At the time of examination

Secondary Outcomes (11)

  • Correlation between ultrasound parameters and the pathological parameters

    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).

    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)

    At the time of examination

  • Diagnostic performance of Normalized Local Variance for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3)

    At the time of examination

  • Diagnostic performance of Dispersion slope for intralobular inflammation (A0 vs. A123, and A012 vs. A3)

    At the time of examination

  • +6 more secondary outcomes

Study Arms (1)

NAFLD patients who are scheduled for liver biopsy

Diagnostic Test: Ultrasound application

Interventions

Ultrasound applicationDIAGNOSTIC_TEST

Shear wave elastography, shear wave dispersion, attenuation imaging, and intensity analysis

NAFLD patients who are scheduled for liver biopsy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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).

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

University of Southern California

Los Angeles, California, 90007, United States

RECRUITING

Rocky Vista University

Parker, Colorado, 80134, United States

RECRUITING

Northwestern University

Evanston, Illinois, 60208, United States

RECRUITING

The Surgical Hospital at Southwoods

Boardman, Ohio, 44512, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

SunYatSen University First Hospital

Guangzhou, China

RECRUITING

SunYatSen University Third Hospital

Guangzhou, China

RECRUITING

Zhejiang University No. 2 Hospital

Hangzhou, China

RECRUITING

University Paris Nord

Paris, France

NOT YET RECRUITING

University of Erlangen

Erlangen, Germany

RECRUITING

University of Leipzig

Leipzig, Germany

RECRUITING

University of Pavia

Pavia, Italy

RECRUITING

Policlinico Umberto I, Univ. La Sapienza

Rome, Italy

RECRUITING

Hyogo Medical University

Hyōgo, Japan

RECRUITING

Kurume University

Kurume, Japan

RECRUITING

Chung-Ang University Hospital

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Charing Cross Hospital / Imperial College London

London, United Kingdom

RECRUITING

Related Publications (1)

  • 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, 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.

    PMID: 39162633DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Katsutoshi Sugimoto, MD, PhD

    Tokyo Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fuminori Moriyasu, MD, PhD

CONTACT

+81-3-3402-3151moriyasy@iuhw.ac.jp

Katsutoshi Sugimoto, MD, PhD

CONTACT

+81-3-3342-6111sugimoto@tokyo-med.ac.jp

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 9, 2019

Study Start

June 15, 2019

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

February 8, 2022

Record last verified: 2022-02

Locations

IT(2)KR(2)FR(1)DE(2)US(5)JP(2)GB(1)CN(3)