NCT01329458

Brief Summary

The aim of the study is to assess the value of contrast enhanced ultrasound in the evaluation of de novo focal liver lesions in clinical practice, in a prospective multi-center design.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 6, 2011

Status Verified

April 1, 2011

Enrollment Period

1 year

First QC Date

April 2, 2011

Last Update Submit

April 5, 2011

Conditions

Focal Nodular Hyperplasia of LiverToxic Liver Disease With Focal Nodular HyperplasiaLiver Metastases

Keywords

FLLCEUSSonoVueHCCLiver metastasesHemangiomasFNH

Outcome Measures

Primary Outcomes (1)

  • evaluation of contrast enhanced ultrasound in the assessment of de novo focal liver lesions

    A CEUS examination will be considered conclusive if, following contrast, the FLL had a typical enhancement pattern according to the EFSUMB guidelines, and inconclusive if the enhancement pattern of the lesions was not in concordance with this guide.

    12 months evaluation

Study Arms (1)

Focal liver lesions

Focal liver lesions: patients discovered with new, uncharacteristic focal liver lesions at standard ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients included in the study will be patients discovered with FLL at standard ultrasound. The focal lesions will be characterized by CEUS and the diagnosis established will be compared with the final diagnosis of the patient. The final diagnosis will be established based on all available imaging and clinical data: computer tomography, MRI, biopsy, follow up information.

You may qualify if:

  • patients diagnosed with de novo FLL at standard ultrasound
  • age \> 18 years, male and female gender
  • informed consent for the contrast enhanced study

You may not qualify if:

  • patients with contraindication for contrast enhanced study: subjects with acute cardiac infarction, with class III/IV cardiac insufficiency, with rhythm disorders and pregnant women
  • Patients diagnosed with simple cysts at standard ultrasound (biliary of hydatid)
  • Patients with known FLL, for example after percutaneous treatment, in which the contrast study is used for the follow up of the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Institutul Clinic Fundeni

Bucharest, Romania

RECRUITING

Institutul Regional de Gastroenterologie-Hepatologie "Octavian Fodor",

Cluj-Napoca, Romania

RECRUITING

Clinica de Gastroenterologie Constanta

Constanța, Romania

RECRUITING

Centrul de Cercetare in Gastroenterologie si Hepatologie

Craiova, Romania

RECRUITING

Clinica de Gastroenterologie si Hepatologie

Timișoara, Romania

RECRUITING

Related Publications (12)

  • Albrecht T, Blomley M, Bolondi L, Claudon M, Correas JM, Cosgrove D, Greiner L, Jager K, Jong ND, Leen E, Lencioni R, Lindsell D, Martegani A, Solbiati L, Thorelius L, Tranquart F, Weskott HP, Whittingham T; EFSUMB Study Group. Guidelines for the use of contrast agents in ultrasound. January 2004. Ultraschall Med. 2004 Aug;25(4):249-56. doi: 10.1055/s-2004-813245. No abstract available.

    PMID: 15300497BACKGROUND

  • Claudon M, Cosgrove D, Albrecht T, Bolondi L, Bosio M, Calliada F, Correas JM, Darge K, Dietrich C, D'Onofrio M, Evans DH, Filice C, Greiner L, Jager K, Jong Nd, Leen E, Lencioni R, Lindsell D, Martegani A, Meairs S, Nolsoe C, Piscaglia F, Ricci P, Seidel G, Skjoldbye B, Solbiati L, Thorelius L, Tranquart F, Weskott HP, Whittingham T. Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS) - update 2008. Ultraschall Med. 2008 Feb;29(1):28-44. doi: 10.1055/s-2007-963785. No abstract available.

    PMID: 18270887BACKGROUND

  • Strobel D, Seitz K, Blank W, Schuler A, Dietrich C, von Herbay A, Friedrich-Rust M, Kunze G, Becker D, Will U, Kratzer W, Albert FW, Pachmann C, Dirks K, Strunk H, Greis C, Bernatik T. Contrast-enhanced ultrasound for the characterization of focal liver lesions--diagnostic accuracy in clinical practice (DEGUM multicenter trial). Ultraschall Med. 2008 Oct;29(5):499-505. doi: 10.1055/s-2008-1027806.

    PMID: 19241506BACKGROUND

  • 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.

    PMID: 19212279BACKGROUND

  • Braun B. Focal liver processes: "better is the enemy of good": CEUS in the fast lane. Ultraschall Med. 2009 Aug;30(4):329-32. doi: 10.1055/s-0028-1109693. Epub 2009 Aug 17. No abstract available. English, German.

    PMID: 19688667BACKGROUND

  • Wilson SR, Greenbaum LD, Goldberg BB. Contrast-enhanced ultrasound: what is the evidence and what are the obstacles? AJR Am J Roentgenol. 2009 Jul;193(1):55-60. doi: 10.2214/AJR.09.2553.

    PMID: 19542395BACKGROUND

  • Trillaud H, Bruel JM, Valette PJ, Vilgrain V, Schmutz G, Oyen R, Jakubowski W, Danes J, Valek V, Greis C. Characterization of focal liver lesions with SonoVue-enhanced sonography: international multicenter-study in comparison to CT and MRI. World J Gastroenterol. 2009 Aug 14;15(30):3748-56. doi: 10.3748/wjg.15.3748.

    PMID: 19673015BACKGROUND

  • Quaia E, Calliada F, Bertolotto M, Rossi S, Garioni L, Rosa L, Pozzi-Mucelli R. Characterization of focal liver lesions with contrast-specific US modes and a sulfur hexafluoride-filled microbubble contrast agent: diagnostic performance and confidence. Radiology. 2004 Aug;232(2):420-30. doi: 10.1148/radiol.2322031401.

    PMID: 15286314BACKGROUND

  • von Herbay A, Vogt C, Willers R, Haussinger D. Real-time imaging with the sonographic contrast agent SonoVue: differentiation between benign and malignant hepatic lesions. J Ultrasound Med. 2004 Dec;23(12):1557-68. doi: 10.7863/jum.2004.23.12.1557.

    PMID: 15557299BACKGROUND

  • Sirli R, Sporea I, Popescu A, Danila M, Sandulescu DL, Saftoiu A, Moga T, Sparchez Z, Cijevschi C, Mihai C, Ioanitescu S, Nedelcu D, Iacob N, Miclaus G, Brisc C, Badea R. Contrast-enhanced ultrasound for the assessment of focal nodular hyperplasia - results of a multicentre study. Med Ultrason. 2021 May 20;23(2):140-146. doi: 10.11152/mu-2912. Epub 2021 Apr 22.

    PMID: 33945596DERIVED

  • Sporea I, Sandulescu DL, Sirli R, Popescu A, Danila M, Sparchez Z, Mihai C, Ioanitescu S, Moga T, Timar B, Brisc C, Nedelcu D, Saftoiu A, Enachescu V, Badea R. Contrast-Enhanced Ultrasound for the Characterization of Malignant versus Benign Focal Liver Lesions in a Prospective Multicenter Experience - The SRUMB Study. J Gastrointestin Liver Dis. 2019 Jun 1;28:191-196. doi: 10.15403/jgld-180.

    PMID: 31204417DERIVED

  • Sirli R, Sporea I, Sandulescu DL, Popescu A, Danila M, Saftoiu A, Sparchez Z, Badea R. Contrast enhanced ultrasound for the diagnosis of liver hemangiomas - results of a Romanian multicentre study. Med Ultrason. 2015 Dec;17(4):444-50. doi: 10.11152/mu.2013.2066.174.csu.

    PMID: 26649337DERIVED

Related Links

MeSH Terms

Conditions

Hemangioma

Condition Hierarchy (Ancestors)

Neoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Mihai A Socaciu, MD, PhD student

CONTACT

0040745587847socacium@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 2, 2011

First Posted

April 6, 2011

Study Start

December 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 6, 2011

Record last verified: 2011-04

Locations

RO(5)