search
Back to results

Evaluation of Innovative Ultrasonic Techniques for Non-invasive Diagnosis of Liver Fibrosis in Patients With Chronic Viral Hepatitis B or C (FIBRECHO)

Primary Purpose

Liver Fibrosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fibroscan® of Echosens, Aixplorer® of Supersonic Imagine, Aplio XG of Toshiba, QRS software developed by Pr I.Bricault, Acuson S2000 of Siemens
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Fibrosis focused on measuring hepatitis, fibrosis, elastography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient with an Ac-HCV positive and RNA HCV positive or AgHBs-positive,
  • naive to treatment or not receiving treatment for viral eradication in six months,
  • patient for whom a liver biopsy size less than 15 mm, regardless of the number of portal tracts present or fragments, is being considered or has been performed between two and one month before inclusion,
  • Patient affiliated to social security or similar regime,
  • patients who signed consent for participation in the study.

Exclusion Criteria:

  • patient with anti-HIV Ac positive (latter result not older than 12 months and in the absence of risk factors)
  • chronic liver disease due to other causes than HCV (hemochromatosis, autoimmune hepatitis, autoimmune disease, metabolic liver disease, alcoholic liver disease, alcoholic liver disease, exposure to toxins ...)
  • chronic alcohol consumption >30g/day in men and >20g/day in women
  • history of severe systemic disease,
  • HCV treatment with anti-viral or anti-fibrotic referred to within the last 6 months,
  • immunosuppressive therapy: corticosteroids, Imurel, cyclosporine, tacrolimus, Cellcep,
  • patient with an active implantable medical device,
  • protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health

Sites / Locations

  • University Hospital

Outcomes

Primary Outcome Measures

In patients with chronic viral hepatitis B or C, evaluate the performance for the diagnosis of significant fibrosis (F≤1 versus F≥2) of elastography in mode supersonic compared with elastography (FibroScan®), the gold standard liver biopsy.
Comparison 2-2 of areas under the ROC curve obtained for the different modalities (Fibroscan® vs Aixplorer®).

Secondary Outcome Measures

Compare the performance for the diagnosis of significant fibrosis of the liver contours regularity quantification and of the homogeneity of the hepatic parenchyma, and biological tests of fibrosis, the gold standard is liver biopsy.
Comparison 2-2 of areas under the ROC curve obtained for the different modalities (Fibrotest®, Fibromètre®, Acoustic Structure Quantification, Quantification of the Surface Regularity, elastography ARFI)
Evaluate the diagnostic performance of each technique (ultrasound innovative and organic) for severe fibrosis (F<3 vs F≥3) and cirrhosis (F<4 vs F≥4).
Comparison 2-2 of areas under the ROC curve obtained for the different modalities (Fibrotest®, Fibromètre®, elastography with Fibroscan®, elastography in mode supersonic, Acoustic Structure Quantification, Quantification of the Surface Regularity, elastography ARFI)
Evaluate the diagnostic performance of all approaches to all stages of fibrosis took 2 by 2 (F1 vs. F2, F2 vs. F3, F3 vs. F4)
Comparison 2-2 of areas under the ROC curve obtained for the different modalities (Fibrotest®, Fibromètre®, elastography with Fibroscan®, elastography in mode supersonic, Acoustic Structure Quantification, Quantification of the Surface Regularity, elastography ARFI)
Evaluate the performance of the main diagnostic modalities chosen from previous results in the two sub-populations: patients with hepatitis B and those with hepatitis C
Comparison of areas under the ROC curve obtained in the two sub-population (hepatisis B and C) for the main diagnostic modalities chosen from previous results.
Kappa intra-observer coefficient of ultrasonic techniques
Propose, based on previous results, a hierarchical strategy for using these innovative ultrasonic techniques used in combination with Fibroscan ® and the biological tests currently available (Fibrotest ®, FibroMetre ®).
proportion of patients correctly classified by the new strategy for each grade of fibrosis.

Full Information

First Posted
December 15, 2011
Last Updated
February 21, 2014
Sponsor
University Hospital, Grenoble
Collaborators
Clinical Investigation Centre for Innovative Technology Network
search

1. Study Identification

Unique Protocol Identification Number
NCT01537965
Brief Title
Evaluation of Innovative Ultrasonic Techniques for Non-invasive Diagnosis of Liver Fibrosis in Patients With Chronic Viral Hepatitis B or C
Acronym
FIBRECHO
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Clinical Investigation Centre for Innovative Technology Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The non-invasive assessment of liver fibrosis in chronic viral hepatitis B and C is now entering clinical practice. It is based on blood tests, especially FibroMetre® and Fibrotest® and on elastography with the Fibroscan®. Despite the overall satisfactory diagnostic performance for all of these tests (AUROC ranging from 0.80 to 0.90 depending on the study) for the discrimination of F≤1 versus F≥2, the positive and negative predictive values , however, are far from be perfect in a given patient. With these technique, failures are also possible and the measures do not meet quality standards that increase the risk of misclassification. It would be particularly useful to have new generation techniques with a better diagnostic performance. In this project, in response to the problems presented above, we propose to evaluate the diagnostic performance of five innovative ultrasonic techniques for the non-invasive diagnosis of fibrosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis
Keywords
hepatitis, fibrosis, elastography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Fibroscan® of Echosens, Aixplorer® of Supersonic Imagine, Aplio XG of Toshiba, QRS software developed by Pr I.Bricault, Acuson S2000 of Siemens
Intervention Description
Five ultrasounds exams are realised: elastography with Fibroscan® ultrasound elastography in supersonic mode with Aixplorer® ultrasound analysis of the surface liver with QRS software, quantification of acoustic structure with Aplio XG, elastography ARFI with Acuson S2000.
Primary Outcome Measure Information:
Title
In patients with chronic viral hepatitis B or C, evaluate the performance for the diagnosis of significant fibrosis (F≤1 versus F≥2) of elastography in mode supersonic compared with elastography (FibroScan®), the gold standard liver biopsy.
Description
Comparison 2-2 of areas under the ROC curve obtained for the different modalities (Fibroscan® vs Aixplorer®).
Time Frame
two years
Secondary Outcome Measure Information:
Title
Compare the performance for the diagnosis of significant fibrosis of the liver contours regularity quantification and of the homogeneity of the hepatic parenchyma, and biological tests of fibrosis, the gold standard is liver biopsy.
Description
Comparison 2-2 of areas under the ROC curve obtained for the different modalities (Fibrotest®, Fibromètre®, Acoustic Structure Quantification, Quantification of the Surface Regularity, elastography ARFI)
Time Frame
two years
Title
Evaluate the diagnostic performance of each technique (ultrasound innovative and organic) for severe fibrosis (F<3 vs F≥3) and cirrhosis (F<4 vs F≥4).
Description
Comparison 2-2 of areas under the ROC curve obtained for the different modalities (Fibrotest®, Fibromètre®, elastography with Fibroscan®, elastography in mode supersonic, Acoustic Structure Quantification, Quantification of the Surface Regularity, elastography ARFI)
Time Frame
two years
Title
Evaluate the diagnostic performance of all approaches to all stages of fibrosis took 2 by 2 (F1 vs. F2, F2 vs. F3, F3 vs. F4)
Description
Comparison 2-2 of areas under the ROC curve obtained for the different modalities (Fibrotest®, Fibromètre®, elastography with Fibroscan®, elastography in mode supersonic, Acoustic Structure Quantification, Quantification of the Surface Regularity, elastography ARFI)
Time Frame
two years
Title
Evaluate the performance of the main diagnostic modalities chosen from previous results in the two sub-populations: patients with hepatitis B and those with hepatitis C
Description
Comparison of areas under the ROC curve obtained in the two sub-population (hepatisis B and C) for the main diagnostic modalities chosen from previous results.
Time Frame
two years
Title
Kappa intra-observer coefficient of ultrasonic techniques
Time Frame
two years
Title
Propose, based on previous results, a hierarchical strategy for using these innovative ultrasonic techniques used in combination with Fibroscan ® and the biological tests currently available (Fibrotest ®, FibroMetre ®).
Description
proportion of patients correctly classified by the new strategy for each grade of fibrosis.
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient with an Ac-HCV positive and RNA HCV positive or AgHBs-positive, naive to treatment or not receiving treatment for viral eradication in six months, patient for whom a liver biopsy size less than 15 mm, regardless of the number of portal tracts present or fragments, is being considered or has been performed between two and one month before inclusion, Patient affiliated to social security or similar regime, patients who signed consent for participation in the study. Exclusion Criteria: patient with anti-HIV Ac positive (latter result not older than 12 months and in the absence of risk factors) chronic liver disease due to other causes than HCV (hemochromatosis, autoimmune hepatitis, autoimmune disease, metabolic liver disease, alcoholic liver disease, alcoholic liver disease, exposure to toxins ...) chronic alcohol consumption >30g/day in men and >20g/day in women history of severe systemic disease, HCV treatment with anti-viral or anti-fibrotic referred to within the last 6 months, immunosuppressive therapy: corticosteroids, Imurel, cyclosporine, tacrolimus, Cellcep, patient with an active implantable medical device, protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Leroy, Pr, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Grenoble
Country
France

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Innovative Ultrasonic Techniques for Non-invasive Diagnosis of Liver Fibrosis in Patients With Chronic Viral Hepatitis B or C

We'll reach out to this number within 24 hrs