Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for Diagnosis of Hepatic Steatosis
A Multicenter Clinical Study on the Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for the Diagnosis of Hepatic Steatosis
1 other identifier
observational
240
1 country
8
Brief Summary
This will be a multi-center, prospective, controlled study. It is expected that about 240 subjects from 10 study centers will be enrolled, and 224 effective subjects will be statistically analyzed in the end, in which 56 effective subjects with stage F0 (25%), 56 effective subjects with stage F1 (25%), 56 effective subjects with stage F2 (25%), 56 effective subjects with stage F3 (25%). By comparison of the result of FibroTouch examination with that of liver biopsy, their specificities, sensitivities and accuracies for diagnosis of liver steatosis will be identified. The patients with liver diseases who need to have a liver biopsy in hospital and meet all of the inclusion criteria and none of the exclusion criteria, may participate in this study. Within two weeks of FibroTouch examination, subjects are required to have qualified histological specimens of liver biopsy for comparation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2014
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 22, 2015
CompletedFirst Posted
Study publicly available on registry
May 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMay 28, 2015
May 1, 2015
1 year
March 22, 2015
May 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The coincidence for diagnosis of hepatic steatosis between fat attenuation parameter (FAP) of FibroTouch and liver biopsy by ROC analysis
Performance of fat attenuation parameter (FAP, dB/m) of FibroTouch will be assessed using ROC analysis for the detection of hepatic steatosis stage F0 (\<5%), stage F1 (5%-33%), stage F2 (34%-66%), and stage F3 (2\>66%) using liver biopsy as the reference.
Within two weeks of FibroTouch examination
Study Arms (4)
F0
Liver Steatosis Grade: \<5%
F1
Liver Steatosis Grade: 5-33%
F2
Liver Steatosis Grade: 34-66%
F3
Liver Steatosis Grade: \> 66%
Interventions
Eligibility Criteria
The subjects with liver diseases who need to have a liver biopsy in hospital and meet all of the inclusion criteria and none of the exclusion criteria, may participate in this study. Within two weeks of FibroTouch examination, subjects are required to have qualified histological specimens of liver biopsy for comparation.
You may qualify if:
- Subject at the age of 18 to 65 years, non-limited gender.
- Within two weeks of FibroTouch examination, qualified histological specimens of liver biopsy are required. Using the liver biopsy needle of 16G or 14CT, puncture and remove more than 2.0 centimeters long liver tissue (including at least 11 portal areas, no less than 6 complete portal areas and the minimum length of specimen should be more than 1.0 centimeter).
- Willing and able to abide by all principles and complete all study procedures.
- Willing and can provide written informed consent form by patient or patient's legal guardian.
You may not qualify if:
- Subject with active or suspected cancer or history of malignant tumor by evidence within 5 years before enrolling. And the subject who has the liver malignant tumors injury cannot participate in this study.
- There is evidence that the subject has a history of alcohol overdoses\* or drug abuse. Definition of alcohol overdoses: 40 gram (g)/day for male and 40 g/day for female. Alcohol intake (g) = the volume of drinking (ml) × alcohol percentage (%, v/v) × 0.8 (g/ml); 1g alcohol is the equal of 25-40 ml of beer, 8-10ml of Chinese rice wine, 5-12ml of (grape) wine, 3-7ml of health care liquor or Chinese spirits.
- Subject with alcoholic liver disease and hepatitis C.
- Pregnant or nursing woman, and subject with a pregnant plan and is unwilling to take contraceptive measures during this study.
- Subject with history of organ transplantation or has functional grafts (except for the cornea or hair graft).
- Subject with non-healing wound on the right upper abdomen at this moment.
- In the investigator's opinion, the subject is unsuitable to participate in the study as he or she has a history of serious illness, or other evidence shown that the subject has any other serious illness.
- Subject who participates in other clinical trial at the same time.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wuxi Hisky Medical Technology Co Ltdlead
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- Guangzhou First People's Hospitalcollaborator
- Ruijin Hospitalcollaborator
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- No.85 Hospital, Changning, Shanghai, Chinacollaborator
- The Second Hospital of Nanjing Medical Universitycollaborator
- Sichuan Academy of Medical Sciencescollaborator
- Second People's Hospital of Hangzhoucollaborator
Study Sites (8)
Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital
Chengdu, China
Guangzhou First Municipal People's Hospital
Guangzhou, China
Second People's Hospital of Hangzhou
Hangzhou, China
The Second Hospital Of Nanjing
Nanjing, China
Ruijin Hospital
Shanghai, China
Shanghai 85 Hospital
Shanghai, China
Shanghai First People's Hospital
Shanghai, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Related Publications (1)
Qu Y, Song YY, Chen CW, Fu QC, Shi JP, Xu Y, Xie Q, Yang YF, Zhou YJ, Li LP, Xu MY, Cai XB, Zhang QD, Yu H, Fan JG, Lu LG. Diagnostic Performance of FibroTouch Ultrasound Attenuation Parameter and Liver Stiffness Measurement in Assessing Hepatic Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Clin Transl Gastroenterol. 2021 Apr 13;12(4):e00323. doi: 10.14309/ctg.0000000000000323.
PMID: 33848277DERIVED
Biospecimen
Liver Biospy Specimens
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lungen LU, MD
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2015
First Posted
May 28, 2015
Study Start
June 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
May 28, 2015
Record last verified: 2015-05