Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study (iLEAD)

February 6, 2022 updated by: Katsutoshi Sugimoto, Tokyo Medical University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • SunYatSen University First Hospital
        • Contact:
          • Xiaoyan XIE
      • Guangzhou, China
        • Recruiting
        • SunYatSen University Third Hospital
        • Contact:
          • Rongqin ZHENG
      • Hangzhou, China
        • Recruiting
        • Zhejiang University No. 2 Hospital
        • Contact:
          • Pintong HUANG
  • France
      • Paris, France
        • Not yet recruiting
        • University Paris Nord
        • Contact:
          • Valerie VILGRAIN
  • Germany
      • Erlangen, Germany
        • Recruiting
        • University of Erlangen
        • Contact:
          • Deike STROBEL
      • Leipzig, Germany
        • Recruiting
        • University of Leipzig
        • Contact:
          • Thomas KARLAS
  • Italy
      • Pavia, Italy
        • Recruiting
        • University of Pavia
        • Contact:
          • Giovanna FERRAIOLI
      • Rome, Italy
        • Recruiting
        • Policlinico Umberto I, Univ. La Sapienza
        • Contact:
          • Vito CANTISANI
  • Japan
      • Hyogo, Japan
        • Recruiting
        • Hyogo Medical University
        • Contact:
          • Hiroko Iijima, MD, PhD
      • Kurume, Japan
        • Recruiting
        • Kurume University
        • Contact:
          • Hirohisa Yano, MD, PhD
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Jae Young LEE
      • Seoul, Korea, Republic of
        • Recruiting
        • Chung-Ang University Hospital
        • Contact:
          • Byung Ihn CHOI
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Charing Cross Hospital / Imperial College London
        • Contact:
          • Adrian LIM
  • United States
    • California
      • Los Angeles, California, United States, 90007
        • Recruiting
        • University of Southern California
        • Contact:
          • Edward GRANT
    • Colorado
      • Parker, Colorado, United States, 80134
        • Recruiting
        • Rocky Vista University
        • Contact:
          • Jing Gao
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Recruiting
        • Northwestern University
        • Contact:
          • Thomas GRANT
    • Ohio
      • Boardman, Ohio, United States, 44512
        • Recruiting
        • The Surgical Hospital at Southwoods
        • Contact:
          • Richard BARR
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Contact:
          • Ted DUBINSKY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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).

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NAFLD patients who are scheduled for liver biopsy
Diagnostic test: Ultrasound application
Shear wave elastography, shear wave dispersion, attenuation imaging, and intensity analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23)
Time Frame: At the time of examination
At the time of examination

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between ultrasound parameters and the pathological parameters
Time Frame: At the time of examination
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
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
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
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
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
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
At the time of examination
Diagnostic performance of the computer aided algorithm for NASH
Time Frame: At the time of examination
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
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
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
At the time of examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokyo Medical University

Investigators

  • Principal Investigator: Katsutoshi Sugimoto, MD, PhD, Tokyo Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2019

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

July 7, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 6, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TokyoMU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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