Contrast Enhanced Ultrasound For The Evaluation Of Focal Liver Lesions

Liver Metastases Clinical Trial

— HepFocUS  

Official title:

Contrast Enhanced Ultrasound for the Evaluation of Focal Liver Lesions - a Multi-center Study on the Usefulness in the Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01329458
• Other study ID #: HepFocUS
• Status: Recruiting
• Phase: N/A
• First received: April 2, 2011
• Last updated: April 5, 2011
• Start date: December 2010
• Est. completion date: December 2011

Study information

• Verified date: April 2011
• Source: Societatea Romana de Ultrasonografie in Medicina si Biologie
• Contact: Mihai A Socaciu, MD, PhD student
• Phone: 0040745587847
• Email: socacium[@]yahoo.com
• Is FDA regulated: No
• Health authority: Romania: National Authority for Scientific Research
• Study type: Observational

Clinical Trial 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.

Description:

Focal liver lesions (FLL) are quite frequently discovered in daily practice at routine ultrasound and sometimes require the use of extensive investigations for a correct diagnosis, thus increasing the costs and duration of diagnosis. On the other hand, due to screening strategies for patients with liver cirrhosis, FLL are discovered very early in these patients, and they must be evaluated in order to establish a therapeutic strategy (including transplantation, surgical resection or percutaneous echoguided procedures).

Contrast enhanced ultrasound (CEUS) using second generation contrast agents is a relatively new imaging modality that allows the characterization of FLL and allows a positive diagnosis based on the vascular pattern of the lesion. The advantages of this method are the low cost as compared with other imaging modalities and the fact that it can be performed immediately after standard abdominal ultrasound, so approximately 5 minutes after CEUS (the total duration of this investigation) a confident diagnosis can be obtained.

The place of CEUS in the diagnostic algorithm of FLL is not very well established. The European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) issued the first Guidelines regarding the use of CEUS in 2004, revised in 2008, in which the main indications of this method are presented.

The purpose of this study is to establish the value of CEUS in the evaluation of de novo FLL in clinical practice.

The study will include patients discovered with de novo FLL at standard ultrasound in which the ultrasound study is not conclusive for the positive diagnosis (the patients with simple cysts or known FLL under CEUS follow up will be excluded form the study). The standard ultrasound will be followed by the contrast study using SonoVue® (Bracco, Italy) as contrast agent. The amount of contrast agent will be documented in every patient (it depends on the ultrasound machine used and the suspected diagnosis). The examination will be performed using the dedicated contrast software of each ultrasound machine used in the study. The investigators shall also document in every patient: the indication for CEUS study, a short history including the presence of chronic hepatopathies or malignancies, the ultrasound machine used and the operator. Each examination will last about 5 min after bolus injection and will be documented by 4 video files no longer than 30 seconds each, containing: The standard study, the arterial phase, the portal phase and the late phase. Additional loops can be stored whenever it is considered necessary.

A CEUS diagnosis will be established based on the contrast study. This will be compared with the final diagnosis which will be established based on all available imaging and clinical data: computer tomography, MRI, biopsy, follow up information. 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.

The stored loops will be also revised by different operators. The study design is prospective, multi-center and will be approved by the ethical review board.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients diagnosed with de novo FLL at standard ultrasound

• age > 18 years, male and female gender

• informed consent for the contrast enhanced study

Exclusion Criteria:

• 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Focal Nodular Hyperplasia
• Focal Nodular Hyperplasia of Liver
• Hyperplasia
• Liver Diseases
• Liver Metastases
• Toxic Liver Disease With Focal Nodular Hyperplasia

Locations

Country	Name	City	State
Romania	Institutul Clinic Fundeni	Bucuresti
Romania	Institutul Regional de Gastroenterologie-Hepatologie "Octavian Fodor",	Cluj-Napoca
Romania	Clinica de Gastroenterologie Constanta	Constanta
Romania	Centrul de Cercetare in Gastroenterologie si Hepatologie	Craiova
Romania	Clinica de Gastroenterologie si Hepatologie	Timisoara

Sponsors (6)

Lead Sponsor	Collaborator
Societatea Romana de Ultrasonografie in Medicina si Biologie	Centrul de Cercetare in Gastroenterologie si Hepatologie, Craiova, Clinica de Gastroenterologie Constanta, Clinica de Gastroenterologie si Hepatologie, UMF Timisoara, Institutul Clinic Fundeni, Bucuresti, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Country where clinical trial is conducted

Romania, 

References & Publications (9)

Albrecht T, Blomley M, Bolondi L, Claudon M, Correas JM, Cosgrove D, Greiner L, Jäger 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. — View Citation

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. English, German. — View Citation

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, Jäger K, Jong Nd, Leen E, Lencioni R, Lindsell D, Martegani A, Meairs S, Nolsøe 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. — View Citation

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. — View Citation

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. — View Citation

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. French. — View Citation

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. — View Citation

von Herbay A, Vogt C, Willers R, Häussinger 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

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