Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study

Status unconfirmed

Conditions studied: Nonalcoholic Steatohepatitis, Ultrasound, Elastography

In brief

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.

Key facts

Study ID

NCT04012242

Run by

Tokyo Medical University

People needed

400

Starts

2019-06-15

Expected to finish

2022-07-31

Last updated by the study team

2022-02-08

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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