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NCT Number: NCT01082419

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARFI measurement

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Inter and intra observer reproducibility

    Time frame: Three 30 min visits in healthy volunteer group.

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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.

Acronym: NARFI

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 8, 2010
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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