Liver FibrosisNARFINCT01082419
Acoustic Radiation Force Impulse Imaging (ARFI) : a New Technique to Assess Liver Elasticity
A study testing ARFI measurement in people with Liver Fibrosis and Liver Cirrhosis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Fibrosis, Liver Cirrhosis, Viral Hepatitis
- What is being tested?
- ARFI measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the 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.
- Conditions
- Liver Fibrosis, Liver Cirrhosis, Viral Hepatitis, Liver Tumour, Cardiac Failure, Biliary Cholestasis
- Being tested
- ARFI measurement
- Keywords
- Liver stiffness measurement, ARFI, fibrosis, hepatopathy
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular, Heart Failure, Fibrosis, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARFI measurementDevice
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.
ARFI measurementDevice
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.
ARFI measurementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | healthy volunteers Receives: Device: ARFI measurement |
| Group B | Other | patients with supposed disease free liver (normal hepatic and pancreatic biochemistry) Receives: Device: ARFI measurement |
| Group D | Other | patients with cirrhosis Receives: Device: ARFI measurement |
| Group E | Other | patients with liver tumour and surgery indication Receives: Device: ARFI measurement |
| Group F | Other | patients with reversible liver diseases and with acute left cardiac insufficiency Receives: Device: ARFI measurement |
| Group C | Other | patients with non cirrhotic hepatopathy Receives: Device: ARFI measurement |
| Group G | Other | patients with reversible liver diseases and with biliary cholestasis Receives: Device: ARFI measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The elasticity parameter will be for each patient the median of ten ARFI values (m/s) in the right liver.
Measured: One or two 30 min visit according to the patient group
Secondary outcomes (2)
Inter and intra observer reproducibility
Measured: Three 30 min visits in healthy volunteer group.
Median (m/s) of ARFI values between before and after effective treatment for liver reversible disease
Measured: From patient admission until patient healing in groups F&G.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nora FRULIO, Md MSc, Principal investigator, University Hospital, BordeauxAdelaïde Doussau, MD, Msc, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082419
- Sponsor's protocol ID
- CHUBX 2009/21
- Other IDs
- 2009-A01088-49
- Acronym
- NARFI
- Status last verified
- Nov 2014
- First submitted
- 5 Mar 2010
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonekamp S, Kamel I, Solga S, Clark J. Can imaging modalities diagnose and stage hepatic fibrosis and cirrhosis accurately? J Hepatol. 2009 Jan;50(1):17-35. doi: 10.1016/j.jhep.2008.10.016. Epub 2008 Nov 8.
PubMed 19022517Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008 May;48(5):835-47. doi: 10.1016/j.jhep.2008.02.008. Epub 2008 Feb 26.
PubMed 18334275Friedrich-Rust M, Ong MF, Martens S, Sarrazin C, Bojunga J, Zeuzem S, Herrmann E. Performance of transient elastography for the staging of liver fibrosis: a meta-analysis. Gastroenterology. 2008 Apr;134(4):960-74. doi: 10.1053/j.gastro.2008.01.034. Epub 2008 Jan 18.
PubMed 18395077Ferraioli G, Gulizia R, Filice C. Real-time elastography in the assessment of liver fibrosis. AJR Am J Roentgenol. 2007 Sep;189(3):W170. doi: 10.2214/AJR.07.2318. No abstract available.
PubMed 17715090Friedrich-Rust M, Ong MF, Herrmann E, Dries V, Samaras P, Zeuzem S, Sarrazin C. Real-time elastography for noninvasive assessment of liver fibrosis in chronic viral hepatitis. AJR Am J Roentgenol. 2007 Mar;188(3):758-64. doi: 10.2214/AJR.06.0322.
PubMed 17312065Frulio N, Laumonier H, Balabaud C, Trillaud H, Bioulac-Sage P. Hepatic congestion plays a role in liver stiffness. Hepatology. 2009 Nov;50(5):1674-5. doi: 10.1002/hep.23109. No abstract available.
PubMed 19670411Frulio N, Balabaud C, Bioulac-Sage P. Can elastometry be used for a better identification of cirrhosis? Clin Res Hepatol Gastroenterol. 2011 Mar;35(3):166-8. doi: 10.1016/j.clinre.2010.12.012. Epub 2011 Feb 23.
PubMed 21349784Laumonier H, Frulio N, Laurent C, Balabaud C, Zucman-Rossi J, Bioulac-Sage P. Focal nodular hyperplasia with major sinusoidal dilatation: a misleading entity. BMJ Case Rep. 2010 Dec 1;2010:bcr0920103311. doi: 10.1136/bcr.09.2010.3311.
PubMed 22798311
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT01082419
- Acronym / sponsor ID
- NARFI / CHUBX 2009/21
- Conditions
- Liver Fibrosis, Liver Cirrhosis, Viral Hepatitis, Liver Tumour, Cardiac Failure, Biliary Cholestasis
- Keywords
- Liver stiffness measurement, ARFI, fibrosis, hepatopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 8 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Device: ARFI measurementhealthy volunteers |
| Group B | Other | Device: ARFI measurementpatients with supposed disease free liver (normal hepatic and pancreatic biochemistry) |
| Group D | Other | Device: ARFI measurementpatients with cirrhosis |
| Group E | Other | Device: ARFI measurementpatients with liver tumour and surgery indication |
| Group F | Other | Device: ARFI measurementpatients with reversible liver diseases and with acute left cardiac insufficiency |
| Group C | Other | Device: ARFI measurementpatients with non cirrhotic hepatopathy |
| Group G | Other | Device: ARFI measurementpatients with reversible liver diseases and with biliary cholestasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARFI measurementARFI 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 | Group A |
| ARFI measurementARFI 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 | Group B, Group C, Group D, Group E |
| ARFI measurementARFI 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. | Device | Group F, Group G |
Primary outcome
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
2 secondary outcomes
Inter and intra observer reproducibility
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 19022517Bonekamp S, Kamel I, Solga S, Clark J. Can imaging modalities diagnose and stage hepatic fibrosis and cirrhosis accurately? J Hepatol. 2009 Jan;50(1):17-35. doi: 10.1016/j.jhep.2008.10.016. Epub 2008 Nov 8.
- Background: PubMed 18334275Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008 May;48(5):835-47. doi: 10.1016/j.jhep.2008.02.008. Epub 2008 Feb 26.
- Background: PubMed 18395077Friedrich-Rust M, Ong MF, Martens S, Sarrazin C, Bojunga J, Zeuzem S, Herrmann E. Performance of transient elastography for the staging of liver fibrosis: a meta-analysis. Gastroenterology. 2008 Apr;134(4):960-74. doi: 10.1053/j.gastro.2008.01.034. Epub 2008 Jan 18.
- Background: PubMed 17715090Ferraioli G, Gulizia R, Filice C. Real-time elastography in the assessment of liver fibrosis. AJR Am J Roentgenol. 2007 Sep;189(3):W170. doi: 10.2214/AJR.07.2318. No abstract available.
- Background: PubMed 17312065Friedrich-Rust M, Ong MF, Herrmann E, Dries V, Samaras P, Zeuzem S, Sarrazin C. Real-time elastography for noninvasive assessment of liver fibrosis in chronic viral hepatitis. AJR Am J Roentgenol. 2007 Mar;188(3):758-64. doi: 10.2214/AJR.06.0322.
- Results publication: PubMed 19670411Frulio N, Laumonier H, Balabaud C, Trillaud H, Bioulac-Sage P. Hepatic congestion plays a role in liver stiffness. Hepatology. 2009 Nov;50(5):1674-5. doi: 10.1002/hep.23109. No abstract available.
- Results publication: PubMed 21349784Frulio N, Balabaud C, Bioulac-Sage P. Can elastometry be used for a better identification of cirrhosis? Clin Res Hepatol Gastroenterol. 2011 Mar;35(3):166-8. doi: 10.1016/j.clinre.2010.12.012. Epub 2011 Feb 23.
- Results publication: PubMed 22798311Laumonier H, Frulio N, Laurent C, Balabaud C, Zucman-Rossi J, Bioulac-Sage P. Focal nodular hyperplasia with major sinusoidal dilatation: a misleading entity. BMJ Case Rep. 2010 Dec 1;2010:bcr0920103311. doi: 10.1136/bcr.09.2010.3311.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora FRULIO, Md MSc principal investigator
University Hospital, Bordeaux
Adelaïde Doussau, MD, Msc study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARFI measurement in people with Liver Fibrosis and Liver Cirrhosis, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01082419, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.