Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study

Ultrasound Clinical Trial

— iLEAD  

Official title:

Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study for Patients With Nonalcoholic Steatohepatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04012242
• Other study ID #: TokyoMU
• Status: Recruiting
• Start date: June 15, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2022
• Source: Tokyo Medical University
• Contact: Fuminori Moriyasu, MD, PhD
• Phone: +81-3-3402-3151
• Email: moriyasy[@]iuhw.ac.jp
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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, a1-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.

Related Conditions & MeSH terms

• Elastography
• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis
• Ultrasound

Intervention

Diagnostic Test:
• Ultrasound application
Shear wave elastography, shear wave dispersion, attenuation imaging, and intensity analysis

Locations

Country	Name	City	State
China	SunYatSen University First Hospital	Guangzhou
China	SunYatSen University Third Hospital	Guangzhou
China	Zhejiang University No. 2 Hospital	Hangzhou
France	University Paris Nord	Paris
Germany	University of Erlangen	Erlangen
Germany	University of Leipzig	Leipzig
Italy	University of Pavia	Pavia
Italy	Policlinico Umberto I, Univ. La Sapienza	Rome
Japan	Hyogo Medical University	Hyogo
Japan	Kurume University	Kurume
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
United Kingdom	Charing Cross Hospital / Imperial College London	London
United States	The Surgical Hospital at Southwoods	Boardman	Ohio
United States	Northwestern University	Evanston	Illinois
United States	University of Southern California	Los Angeles	California
United States	Rocky Vista University	Parker	Colorado
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo Medical University

Countries where clinical trial is conducted

United States,  China,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23)		At the time of examination
Secondary	Correlation between ultrasound parameters and the pathological parameters		At the time of examination
Secondary	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
Secondary	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
Secondary	Diagnostic performance of Normalized Local Variance for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3)		At the time of examination
Secondary	Diagnostic performance of Dispersion slope for intralobular inflammation (A0 vs. A123, and A012 vs. A3)		At the time of examination
Secondary	Diagnostic performance of Attenuation value for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3)		At the time of examination
Secondary	Diagnostic performance of Liver/Kidney Intensity Ratio for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3)		At the time of examination
Secondary	Diagnostic performance of the computer aided algorithm for NASH		At the time of examination
Secondary	Diagnostic performance of MRI-PDFF for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3).		At the time of examination
Secondary	Diagnostic performance of CAP for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3).		At the time of examination
Secondary	Diagnostic performance of MRE for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4).		At the time of examination