Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for Diagnosis of Hepatic Steatosis

Fatty Liver Clinical Trial

Official title:

A Multicenter Clinical Study on the Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for the Diagnosis of Hepatic Steatosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02456766
• Other study ID #: TG1310FT
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2015
• Last updated: May 27, 2015
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: May 2015
• Source: Wuxi Hisky Medical Technology Co Ltd
• Contact: Peng LU, Bachelor
• Phone: +86-10-62701872
• Email: lupeng[@]fibrotouch.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis
• Liver Steatosis

Intervention

Device:
• FibroTouch

Procedure:
• Liver Biopsy

Locations

Country	Name	City	State
China	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

Sponsors (9)

Lead Sponsor	Collaborator
Wuxi Hisky Medical Technology Co Ltd	Guangzhou First Municipal People’s Hospital, No.85 Hospital, Changning, Shanghai, China, Ruijin Hospital, Second People's Hospital of Hangzhou, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Sichuan Academy of Medical Sciences &Sichuan Provincial People’s Hospital, The Second Hospital of Nanjing, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No