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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04012242
Other study ID # TokyoMU
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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