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Focal Liver LesionsNCT00243633

Characterization of Focal Liver Lesions by Real-time Contrast-enhanced Ultrasound Imaging (CEUS)

A study testing Real-time contrast-enhanced ultrasound sonography in people with Focal Liver Lesions and Liver Cancer, run by University Hospital, Tours at 15 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The conventional sonography is frequently used to detect incidental focal liver lesions because of its availability, innocuity and low cost. Nevertheless, sensibility and specificity of conventional sonography does not exceed 70% for tumoral affections. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Focal Liver Lesions, Liver Cancer, Liver Cirrhosis
What is being tested?
Real-time contrast-enhanced ultrasound sonography
Type of treatment
Surgery or procedure
How many people
878 participants
Where
15 sitesFrance
Study dates
Apr 2005to Aug 2007
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Target focal liver lesion of size lower than 10 cm and higher than 5 mm detected by conventional ultrasonography

Who cannot join

  • Patients with acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: myocardial infarction, recent coronary artery intervention, acute cardiac failure (within last month), acute endocarditis and prosthetic valves.
  • Pregnant and lactating women

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • CHRU d'ANGERS

    Angers, 49033

  • Hôpital Saint-Jacques, CHRU Besancon

    Besançon, 25000

  • Hôpital Saint-André, CHRU Bordeaux

    Bordeaux, 33075

  • Hôpital Beaujon, Assistance Publique Hôpitaux de Paris

    Clichy, 92118

  • Hospices Civils de Lyon

    Lyon, 69003

  • Hôpital Saint-Eloi, CHRU Montpellier

    Montpellier, 34295

  • Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris

    Paris, 75651

  • Hôpital Necker, Assistance Publique Hôpitaux de Paris

    Paris, 75743

  • Hôpital La Milétrie, CHRU Poitiers

    Poitiers, 86000

  • Hôpital Robert Debré, CHRU Reims

    Reims, 51092

  • Hôpital Nord, CHRU Saint-Etienne

    Saint-Etienne, 42055

  • Hôpital Bretonneau, CHRU Tours

    Tours, 37044

  • Service de Radiologie, Hôpital d'Enfants de Brabois

    Vandœuvre-lès-Nancy, 54511

  • Hôpital Paul Brousse, Assistance Publique Hôpitaux de Paris

    Villejuif, 94804

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

The conventional sonography is frequently used to detect incidental focal liver lesions because of its availability, innocuity and low cost. Nevertheless, sensibility and specificity of conventional sonography does not exceed 70% for tumoral affections. Consequently the interest of this practice must be reconsidered by studying its ratio cost/diagnosis contribution.

These limitations of conventional sonography have led to the use of other imaging modalities and invasive or costly procedures such as computed tomography (CT), magnetic resonance imaging (MRI) or biopsy. The availability of real-time contrast-enhanced ultrasound imaging (CEUS) has changed the strategy in the characterization of focal liver lesions, on healthy or cirrhotic liver in a neoplastic context or not, without inconvenience for the patient.

The aim of the present study is to evaluate the place of CEUS in term of diagnostic relevance and catch of load cost, in the characterization of focal liver lesions detected but not characterized by CT or conventional sonography.

Being tested
Real-time contrast-enhanced ultrasound sonography
Keywords
focal liver lesions, contrast-enhanced ultrasound sonography, cirrhosis, suspected liver metastases, suspected liver cirrhosis
Medical subject headings
Liver Neoplasms, Liver Cirrhosis, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Real-time contrast-enhanced ultrasound sonographyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medical and economic interest of CEUS

Secondary outcomes (3)

  1. Method acceptability

  2. Contrast-enhanced ultrasound sonography tolerance

  3. Harmony inter-readers

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionDec 2006
  4. Study completionAug 2007

Resources

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
Single group
Masking
None (open label)
Enrolment
878 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00243633
Sponsor's protocol ID
CIT 05 - FT / ECUS
Status last verified
Dec 2025
First submitted
21 Oct 2005
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No

Publications

  • Kim TK, Choi BI, Hong HS, Choi BY, Han JK. Improved imaging of hepatic metastases with delayed pulse inversion harmonic imaging using a contrast agent SH U 508A: preliminary study. Ultrasound Med Biol. 2000 Nov;26(9):1439-44. doi: 10.1016/s0301-5629(00)00268-4.

    PubMed 11179618

  • Albrecht T, Blomley MJ, Burns PN, Wilson S, Harvey CJ, Leen E, Claudon M, Calliada F, Correas JM, LaFortune M, Campani R, Hoffmann CW, Cosgrove DO, LeFevre F. Improved detection of hepatic metastases with pulse-inversion US during the liver-specific phase of SHU 508A: multicenter study. Radiology. 2003 May;227(2):361-70. doi: 10.1148/radiol.2272011833. Epub 2003 Mar 20.

    PubMed 12649417

  • Quaia E, Bertolotto M, Forgacs B, Rimondini A, Locatelli M, Mucelli RP. Detection of liver metastases by pulse inversion harmonic imaging during Levovist late phase: comparison with conventional ultrasound and helical CT in 160 patients. Eur Radiol. 2003 Mar;13(3):475-83. doi: 10.1007/s00330-002-1670-1. Epub 2002 Sep 26.

    PubMed 12594549

  • Bernatik T, Becker D, Neureiter D, Hansler J, Frieser M, Schaber S, Hahn EG, Strobel D. [Detection of liver metastases--comparison of contrast--enhanced ultrasound using first versus second generation contrast agents]. Ultraschall Med. 2003 Jun;24(3):175-9. doi: 10.1055/s-2003-40060. German.

    PubMed 12817311

  • Basilico R, Blomley MJ, Harvey CJ, Filippone A, Heckemann RA, Eckersley RJ, Cosgrove DO. Which continuous US scanning mode is optimal for the detection of vascularity in liver lesions when enhanced with a second generation contrast agent? Eur J Radiol. 2002 Mar;41(3):184-91. doi: 10.1016/s0720-048x(01)00459-4.

    PubMed 11861092

  • Leen E, Angerson WJ, Yarmenitis S, Bongartz G, Blomley M, Del Maschio A, Summaria V, Maresca G, Pezzoli C, Llull JB. Multi-centre clinical study evaluating the efficacy of SonoVue (BR1), a new ultrasound contrast agent in Doppler investigation of focal hepatic lesions. Eur J Radiol. 2002 Mar;41(3):200-6. doi: 10.1016/s0720-048x(01)00457-0.

    PubMed 11861094

  • Tranquart F, Bleuzen A, Tchuenbou J. [Contrast ultrasound imaging in focal liver lesions: diagnostic value and guidelines]. J Radiol. 2004 May;85(5 Pt 2):680-9. doi: 10.1016/s0221-0363(04)97649-4. French.

    PubMed 15238869

  • Tranquart F, Correas JM, Ladam Marcus V, Manzoni P, Vilgrain V, Aube C, Elmaleh A, Chami L, Claudon M, Cuilleron M, Diris B, Garibaldi F, Lucidarme O, Marion D, Beziat C, Rode A, Tasu JP, Trillaud H, Bleuzen A, Le Gouge A, Giraudeau B, Rusch E. [Real-time contrast-enhanced ultrasound in the evaluation of focal liver lesions: diagnostic efficacy and economical issues from a French multicentric study]. J Radiol. 2009 Jan;90(1 Pt 2):109-22. doi: 10.1016/s0221-0363(09)70089-7. French.

    PubMed 19212279

Questions about this trial

What is this clinical trial studying?

A study testing Real-time contrast-enhanced ultrasound sonography in people with Focal Liver Lesions and Liver Cancer, run by University Hospital, Tours at 15 sites 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 1 inclusion and 2 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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?

Medical and economic interest of CEUS. 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 NCT00243633, 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 23 Dec 2025.

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