Quantitative Detection Efficiency of UDFF for Nonalcoholic Fatty Liver Disease
UDFF
1 other identifier
observational
300
2 countries
14
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide, affecting more than 25 % of the population globally. Approximately 20 % - 25 % of NAFLD patients can develop nonalcoholic steatohepatitis (NASH), which leads to more rapid progression from fibrosis to cirrhosis, and even liver failure or hepatocellular carcinoma (HCC). Early detection and treatment may halt or reverse NAFLD progression. Although liver biopsy has been the well-accepted clinical reference standard for both diagnosis and staging of the different histological changes in NAFLD, this procedure is invasive with complications such as bleeding and infection, and is unreliable for quantifying steatosis due to sampling errors. Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) currently has been accepted as the preferred alternative to the histological assessment of hepatic steatosis in patients with NAFLD. Magnetic resonance elastography (MRE) provide additional information of inflammation and fibrotic components of NAFLD. However, important limitations hinder the widespread clinical application of MRI, including high cost, low availability, long scan times and exclusion of patients with metal implants. Ultrasound (US) has been recommended by several guidelines as the first-line screening tool for patients at risk of NAFLD. The developed ultrasound-derived fat fraction (UDFF) is designed to assess hepatic steatosis by estimating the frequency-dependent attenuation coefficient (AC) and backscatter coefficient (BSC) through processing acoustic radiofrequency (RF) signals returned from the liver tissue as fat vesicles in hepatocytes have a different characteristic impedance compared to normal liver tissue. UDFF is available on the Acuson Sequoia ultrasound system (Simens Healthineers, Mountain View, CA, USA), with reference to integrated phantom data to correct for system impact, and produces a UDFF value presented as a fat fraction (%), which is potentially related to MRI-PDFF and can be directly compared with MRI-PDFF. In addition, automatic point shear wave elastography (auto-pSWE) is available on the Acuson Sequoia ultrasound system to obtain liver stiffness measurement (LSM) for assessing hepatic fibrosis, simultaneously with UDFF measurement. The prospective, multicenter study aims to evaluate the efficiency of UDFF as a quantitative non-invasive alternative for NAFLD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Shorter than P25 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 14, 2023
CompletedFirst Posted
Study publicly available on registry
April 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedApril 10, 2023
March 1, 2023
12 months
March 14, 2023
April 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The efficiency of UDFF (in %) for hepatic steatosis in comparison with MRI-PDFF (in %).
Evaluate the diagnosis performance of ultrasound-derived fat fraction (UDFF) as a quantitative non-invasive alternative for diagnosing and grading of hepatic steatosis in NAFLD patients, taking MRI-PDFF as the reference standard.
1 years
Secondary Outcomes (1)
The efficiency of auto-pSWE (in kPa) for hepatic fibrosis in comparison with MRE (in kPa).
1 years
Study Arms (2)
Training cohort
Patients were fulfilled diagnosis of non-alcoholic fatty liver disease based on radiological and clinical manifestation. Patients were fulfilled diagnosis of hepatic fibrosis based on radiological and clinical manifestation.
Validation cohort
Patients were fulfilled diagnosis of non-alcoholic fatty liver disease based on radiological and clinical manifestation. Patients were fulfilled diagnosis of hepatic fibrosis based on radiological and clinical manifestation.
Interventions
All patients underwent measurement of UDFF for hepatic fat fraction and auto-pSWE for hepatic fibrosis. All patients underwent measurement of MRI-PDFF for hepatic fat fraction and MRE for hepatic fibrosis as reference standard.
Eligibility Criteria
Patients were fulfilled diagnosis of non-alcoholic fatty liver disease based on radiological and clinical manifestation.
You may qualify if:
- be at least 18 years of age.
- fulfilled diagnosis of non-alcoholic fatty liver disease based on radiological (MRI-PDFF values \> 5%) and clinical manifestation.
- fulfilled diagnosis of hepatic fibrosis with non-alcoholic fatty liver disease based on radiological (LSM by MRE \> 3.02kPa) and clinical manifestation.
- Willing to participate in this research and sign the informed consent.
You may not qualify if:
- with liver dysfunction at the terminal stage or are ready for liver transplantation.
- with viral hepatitis, autoimmune hepatitis, and alpha-1-antitrypsin deficiency.
- history of excessive drinking (the amount of alcohol consumed by women is more than 140 grams per week, and that of men is more than 210 grams per week).
- unable to cooperate with ultrasound examinations.
- have taken liver damage drugs within the past six months.
- with massive ascites.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicinelead
- Zhongda Hospitalcollaborator
- Zhejiang Universitycollaborator
- Lishui Country People's Hospitalcollaborator
- Shandong Public Health Clinical Centercollaborator
- Affiliated Hangzhou Xixi Hospital, Zhejiang University School of Medicinecollaborator
- First Affiliated Hospital of Wenzhou Medical Universitycollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- The Second Hospital of Anhui Medical Universitycollaborator
- The People's Hospital of Bozhoucollaborator
- The First Affiliated Hospital of Xiamen Universitycollaborator
- The First Hospital of Jilin Universitycollaborator
- Kliniken Hirslanden Beau Site, Salem und Permancencecollaborator
- Third People's Hospital of Zhenjiang, Jiangsu Universitycollaborator
Study Sites (14)
The People's Hospital of Bozhou
Bozhou, Anhui, 236000, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000, China
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Zhe Third People's Hospital of Zhenjiang
Zhenjiang, Jiangsu, 212021, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130000, China
Shandong Public Health Clinical Center
Jinan, Shandong, 250000, China
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Affiliated Hangzhou Xixi Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Lishui People's Hospital
Lishui, Zhejiang, 323000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Kliniken Hirslanden Beau Site, Salem und Permancence
Bern, Canton of Bern, 200032, Switzerland
Related Publications (13)
Ferraioli G, Berzigotti A, Barr RG, Choi BI, Cui XW, Dong Y, Gilja OH, Lee JY, Lee DH, Moriyasu F, Piscaglia F, Sugimoto K, Wong GL, Wong VW, Dietrich CF. Quantification of Liver Fat Content with Ultrasound: A WFUMB Position Paper. Ultrasound Med Biol. 2021 Oct;47(10):2803-2820. doi: 10.1016/j.ultrasmedbio.2021.06.002. Epub 2021 Jul 18.
PMID: 34284932RESULTSanyal AJ, Brunt EM, Kleiner DE, Kowdley KV, Chalasani N, Lavine JE, Ratziu V, McCullough A. Endpoints and clinical trial design for nonalcoholic steatohepatitis. Hepatology. 2011 Jul;54(1):344-53. doi: 10.1002/hep.24376.
PMID: 21520200RESULTSimon TG, Roelstraete B, Khalili H, Hagstrom H, Ludvigsson JF. Mortality in biopsy-confirmed nonalcoholic fatty liver disease: results from a nationwide cohort. Gut. 2021 Jul;70(7):1375-1382. doi: 10.1136/gutjnl-2020-322786. Epub 2020 Oct 9.
PMID: 33037056RESULTZhang MH, Li J, Zhu XY, Zhang YQ, Ye ST, Leng YR, Yang T, Zhang H, Kong LY. Physalin B ameliorates nonalcoholic steatohepatitis by stimulating autophagy and NRF2 activation mediated improvement in oxidative stress. Free Radic Biol Med. 2021 Feb 20;164:1-12. doi: 10.1016/j.freeradbiomed.2020.12.020. Epub 2021 Jan 1.
PMID: 33388433RESULTChitturi S, Farrell GC, Hashimoto E, Saibara T, Lau GK, Sollano JD; Asia-Pacific Working Party on NAFLD. Non-alcoholic fatty liver disease in the Asia-Pacific region: definitions and overview of proposed guidelines. J Gastroenterol Hepatol. 2007 Jun;22(6):778-87. doi: 10.1111/j.1440-1746.2007.05001.x.
PMID: 17565630RESULTEuropean Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. Diabetologia. 2016 Jun;59(6):1121-40. doi: 10.1007/s00125-016-3902-y. No abstract available.
PMID: 27053230RESULTKim SH, Lee JM, Kim JH, Kim KG, Han JK, Lee KH, Park SH, Yi NJ, Suh KS, An SK, Kim YJ, Son KR, Lee HS, Choi BI. Appropriateness of a donor liver with respect to macrosteatosis: application of artificial neural networks to US images--initial experience. Radiology. 2005 Mar;234(3):793-803. doi: 10.1148/radiol.2343040142. Epub 2005 Jan 21.
PMID: 15665225RESULTHernaez R, Lazo M, Bonekamp S, Kamel I, Brancati FL, Guallar E, Clark JM. Diagnostic accuracy and reliability of ultrasonography for the detection of fatty liver: a meta-analysis. Hepatology. 2011 Sep 2;54(3):1082-1090. doi: 10.1002/hep.24452.
PMID: 21618575RESULTDasarathy S, Dasarathy J, Khiyami A, Joseph R, Lopez R, McCullough AJ. Validity of real time ultrasound in the diagnosis of hepatic steatosis: a prospective study. J Hepatol. 2009 Dec;51(6):1061-7. doi: 10.1016/j.jhep.2009.09.001. Epub 2009 Sep 20.
PMID: 19846234RESULTMarshall RH, Eissa M, Bluth EI, Gulotta PM, Davis NK. Hepatorenal index as an accurate, simple, and effective tool in screening for steatosis. AJR Am J Roentgenol. 2012 Nov;199(5):997-1002. doi: 10.2214/AJR.11.6677.
PMID: 23096171RESULTWebb M, Yeshua H, Zelber-Sagi S, Santo E, Brazowski E, Halpern Z, Oren R. Diagnostic value of a computerized hepatorenal index for sonographic quantification of liver steatosis. AJR Am J Roentgenol. 2009 Apr;192(4):909-14. doi: 10.2214/AJR.07.4016.
PMID: 19304694RESULTLabyed Y, Milkowski A. Novel Method for Ultrasound-Derived Fat Fraction Using an Integrated Phantom. J Ultrasound Med. 2020 Dec;39(12):2427-2438. doi: 10.1002/jum.15364. Epub 2020 Jun 11.
PMID: 32525261RESULTGao J, Wong C, Maar M, Park D. Reliability of performing ultrasound derived SWE and fat fraction in adult livers. Clin Imaging. 2021 Dec;80:424-429. doi: 10.1016/j.clinimag.2021.08.025. Epub 2021 Sep 17.
PMID: 34543866RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jiangao Fan, M.D.
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
- PRINCIPAL INVESTIGATOR
Xiaolong Qi, M.D.
Zhongda Hospital
- STUDY DIRECTOR
Yi Dong, M.D.
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2023
First Posted
April 6, 2023
Study Start
January 1, 2023
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
April 10, 2023
Record last verified: 2023-03