Acoustic Radiation Force Impulse Imaging (ARFI) : a New Technique to Assess Liver Elasticity (NARFI)

May 11, 2026 updated by: University Hospital, Bordeaux

Acoustic Radiation Force Impulse Imaging (ARFI) : a New Technique to Assess Liver Elasticity - Norms in ARFI: Distribution and Reproducibility of ARFI Values in Disease-free Livers or Pathological Livers.

Liver stiffness measurement (LSM) by non invasive methods is increasingly used to estimate liver fibrosis in patients with chronic liver diseases. However, there is growing evidence that fibrosis is not the only determinant of liver stiffness. Indeed inflammation, cholestasis, congestion could also interfere with stiffness measurements. Acoustic radiation force impulse imaging (ARFI) is a new technology to perform real time LSM. Using a standard ultrasonographic probe, it offers elastography with a flexible metering box at variable depth, allowing the examination of specific area.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are many causes of chronic liver diseases such as hepatitis C infection, hepatitis B infection, alcohol, NAFLD (non-alcoholic fatty liver disease), drugs and auto-immune liver disease.

Although the causes differ the pathological response to injury tends to be similar leading to fibrosis and cirrhosis.

Liver biopsy is the current gold standard for the assessment of liver fibrosis but is poorly suited for active monitoring because of its expense and morbidity. Thus, development of alternatives that are safe, inexpensive, and reliable is a priority.

Liver stiffness measurement (LSM) by non invasive method is increasingly used to estimate liver fibrosis in patient with chronic liver disease. Acoustic radiation force impulse imaging (ARFI) is a new technology to perform real time LSM. Using a standard ultrasonographic probe, it offers elastography with a flexible metering box at variable depth, allowing the examination of specific area.

The purpose of this work was to evaluate by ARFI, the efficiency of this new technique, the reproducibility inter and intra observer, and the liver elasticity obtained by this method in different patient groups.

The primary endpoint of this work is to evaluate by ARFI, the efficiency of the technique, the reproducibility inter and intra observer, and the elasticity of liver in 6 different patient groups and healthy volunteers.

The different population groups are:

  • healthy volunteers Group A
  • patients with supposed disease free liver (normal hepatic and pancreatic biochemistry). Group B
  • patients with non cirrhotic hepatopathy. Group C
  • patients with cirrhosis. Group D
  • patients with liver tumour and surgery indication. Group E

  • patients with reversible liver diseases:

    • patients with acute left cardiac insufficiency. Group F
    • patients with biliary cholestasis. Group G

ARFI measurements will be performed in a single liver ultrasound exam visit except for patients with reversible liver diseases who will have a second visit with ARFI measurement after clinical healing. The ARFI values are expressed as a speed in m/s.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33075
        • University Hospital Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Man or Woman
  • Age> 18 years old
  • Able to understand the study and to give informed consent
  • Informed consent signed by patient and investigator before any study required examination
  • With a valid health insurance
  • Groups specific inclusion criteria are:
  • Group A : healthy volunteers without known liver disease
  • Group B : voluntary patients without known liver disease
  • Group C and D Patient with a diagnosed chronic liver disease
  • Group E : patients with liver tumors (benign or malignant) with surgical indication
  • Group F : patients with acute right heart insufficiency diagnosed by a cardiologist
  • Group G :patients with biliary cholestasis and imaging evidence of biliary dilatation

Exclusion Criteria:

  • Patient under 18 years old
  • Not able to understand the study or to give their consent.
  • Pregnant woman
  • Severe respiratory insufficiency
  • Unable to perform a "light" apnea .
  • hemodynamic instability (cardiogenic shock, septic or anaphylactic) possibility of disruption of the elasticity and inability to carry patient.
  • Chronic heart insufficiency.
  • deprived of their liberty by court

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A
healthy volunteers
Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For group A the measurement is made by a second and a third investigator during the same examination.

Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For all other groups (B, C, D, E) ARFI is measured only once.

Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For groups F and G : ARFI is measured again after clinical healing.
Other: Group B
patients with supposed disease free liver (normal hepatic and pancreatic biochemistry)
Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For group A the measurement is made by a second and a third investigator during the same examination.

Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For all other groups (B, C, D, E) ARFI is measured only once.

Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For groups F and G : ARFI is measured again after clinical healing.
Other: Group D
patients with cirrhosis
Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For group A the measurement is made by a second and a third investigator during the same examination.

Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For all other groups (B, C, D, E) ARFI is measured only once.

Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For groups F and G : ARFI is measured again after clinical healing.
Other: Group E
patients with liver tumour and surgery indication
Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For group A the measurement is made by a second and a third investigator during the same examination.

Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For all other groups (B, C, D, E) ARFI is measured only once.

Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For groups F and G : ARFI is measured again after clinical healing.
Other: Group F
patients with reversible liver diseases and with acute left cardiac insufficiency
Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For group A the measurement is made by a second and a third investigator during the same examination.

Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For all other groups (B, C, D, E) ARFI is measured only once.

Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For groups F and G : ARFI is measured again after clinical healing.
Other: Group C
patients with non cirrhotic hepatopathy
Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For group A the measurement is made by a second and a third investigator during the same examination.

Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For all other groups (B, C, D, E) ARFI is measured only once.

Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For groups F and G : ARFI is measured again after clinical healing.
Other: Group G
patients with reversible liver diseases and with biliary cholestasis
Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For group A the measurement is made by a second and a third investigator during the same examination.

Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For all other groups (B, C, D, E) ARFI is measured only once.

Device: ARFI measurement

ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a "light" apnea.

For groups F and G : ARFI is measured again after clinical healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The elasticity parameter will be for each patient the median of ten ARFI values (m/s) in the right liver.
Time Frame: One or two 30 min visit according to the patient group
One or two 30 min visit according to the patient group

Secondary Outcome Measures

Outcome Measure
Time Frame
Inter and intra observer reproducibility
Time Frame: Three 30 min visits in healthy volunteer group.
Three 30 min visits in healthy volunteer group.
Median (m/s) of ARFI values between before and after effective treatment for liver reversible disease
Time Frame: From patient admission until patient healing in groups F&G.
From patient admission until patient healing in groups F&G.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Nora FRULIO, Md MSc, University Hospital, Bordeaux
  • Study Chair: Adelaïde Doussau, MD, Msc, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

March 5, 2010

First Submitted That Met QC Criteria

March 5, 2010

First Posted (Estimated)

March 8, 2010

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2009/21
  • 2009-A01088-49 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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