Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study

NCT ID: NCT04012242

Last Updated: 2022-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-15

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nonalcoholic Steatohepatitis Ultrasound Elastography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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NAFLD patients who are scheduled for liver biopsy

Ultrasound application

Intervention Type DIAGNOSTIC_TEST

Shear wave elastography, shear wave dispersion, attenuation imaging, and intensity analysis

Interventions

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Ultrasound application

Shear wave elastography, shear wave dispersion, attenuation imaging, and intensity analysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tokyo Medical University

OTHER

Sponsor Role lead

Responsible Party

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Katsutoshi Sugimoto

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katsutoshi Sugimoto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tokyo Medical University

Locations

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University of Southern California

Los Angeles, California, United States

Site Status RECRUITING

Rocky Vista University

Parker, Colorado, United States

Site Status RECRUITING

Northwestern University

Evanston, Illinois, United States

Site Status RECRUITING

The Surgical Hospital at Southwoods

Boardman, Ohio, United States

Site Status RECRUITING

University of Washington

Seattle, Washington, United States

Site Status RECRUITING

SunYatSen University First Hospital

Guangzhou, , China

Site Status RECRUITING

SunYatSen University Third Hospital

Guangzhou, , China

Site Status RECRUITING

Zhejiang University No. 2 Hospital

Hangzhou, , China

Site Status RECRUITING

University Paris Nord

Paris, , France

Site Status NOT_YET_RECRUITING

University of Erlangen

Erlangen, , Germany

Site Status RECRUITING

University of Leipzig

Leipzig, , Germany

Site Status RECRUITING

University of Pavia

Pavia, , Italy

Site Status RECRUITING

Policlinico Umberto I, Univ. La Sapienza

Rome, , Italy

Site Status RECRUITING

Hyogo Medical University

Hyōgo, , Japan

Site Status RECRUITING

Kurume University

Kurume, , Japan

Site Status RECRUITING

Chung-Ang University Hospital

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Charing Cross Hospital / Imperial College London

London, , United Kingdom

Site Status RECRUITING

Countries

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United States China France Germany Italy Japan South Korea United Kingdom

Central Contacts

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Fuminori Moriyasu, MD, PhD

Role: CONTACT

+81-3-3402-3151

Katsutoshi Sugimoto, MD, PhD

Role: CONTACT

+81-3-3342-6111

Facility Contacts

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Edward GRANT

Role: primary

Jing GAO

Role: primary

Thomas GRANT

Role: primary

Richard BARR

Role: primary

Ted DUBINSKY

Role: primary

Xiaoyan XIE

Role: primary

Rongqin ZHENG

Role: primary

Pintong HUANG

Role: primary

Valerie VILGRAIN

Role: primary

Deike STROBEL

Role: primary

Thomas KARLAS

Role: primary

Giovanna FERRAIOLI

Role: primary

Vito CANTISANI

Role: primary

Hiroko Iijima, MD, PhD

Role: primary

Hirohisa Yano, MD, PhD

Role: primary

Byung Ihn CHOI

Role: primary

Jae Young LEE

Role: primary

Adrian LIM

Role: primary

References

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Sugimoto K, Moriyasu F, Dioguardi Burgio M, Vilgrain V, Jesper D, Strobel D, Blank V, Karlas T, Grant EG, Kelahan LC, Gabriel H, Choi BI, Nishimura T, Iijima H, Dubinsky TJ, Gao J, Lee DH, Lee JY, Zhao Y, Huang P, Zeng J, Lim A, Xie X, Barr RG, Cantisani V, Ferraioli G, Sakamaki K, Itoi T, Kage M, Yano H. US Markers and Necroinflammation, Steatosis, and Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease: The iLEAD Study. Radiology. 2024 Aug;312(2):e233377. doi: 10.1148/radiol.233377.

Reference Type DERIVED
PMID: 39162633 (View on PubMed)

Other Identifiers

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TokyoMU

Identifier Type: -

Identifier Source: org_study_id

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