Ultrasound Clinical Trial
— iLEADOfficial title:
Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study for Patients With Nonalcoholic Steatohepatitis
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 |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Tokyo Medical University |
United States, China, France, Germany, Italy, Japan, Korea, Republic of, United Kingdom,
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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