Contrast Enhanced Ultrasound For The Evaluation Of Focal Liver Lesions (HepFocUS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Societatea Romana de Ultrasonografie in Medicina si Biologie.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Centrul de Cercetare in Gastroenterologie si Hepatologie, Craiova
Clinica de Gastroenterologie si Hepatologie, UMF Timisoara
Institutul Regional de Gastroenterologie-Hepatologie "prof.dr. Octavian Fodor", Cluj-Napoca
Institutul Clinic Fundeni, Bucuresti
Clinica de Gastroenterologie Constanta
Information provided by:
Societatea Romana de Ultrasonografie in Medicina si Biologie
ClinicalTrials.gov Identifier:
NCT01329458
First received: April 2, 2011
Last updated: April 5, 2011
Last verified: April 2011
  Purpose

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.


Condition
Focal Nodular Hyperplasia of Liver
Toxic Liver Disease With Focal Nodular Hyperplasia
Liver Metastases

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Contrast Enhanced Ultrasound for the Evaluation of Focal Liver Lesions - a Multi-center Study on the Usefulness in the Clinical Practice

Resource links provided by NLM:


Further study details as provided by Societatea Romana de Ultrasonografie in Medicina si Biologie:

Primary Outcome Measures:
  • evaluation of contrast enhanced ultrasound in the assessment of de novo focal liver lesions [ Time Frame: 12 months evaluation ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1500
Study Start Date: December 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Focal liver lesions
Focal liver lesions: patients discovered with new, uncharacteristic focal liver lesions at standard ultrasound

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329458

Contacts
Contact: Mihai A Socaciu, MD, PhD student 0040745587847 socacium@yahoo.com

Locations
Romania
Institutul Clinic Fundeni Recruiting
Bucuresti, Romania
Institutul Regional de Gastroenterologie-Hepatologie "Octavian Fodor", Recruiting
Cluj-Napoca, Romania
Clinica de Gastroenterologie Constanta Recruiting
Constanta, Romania
Centrul de Cercetare in Gastroenterologie si Hepatologie Recruiting
Craiova, Romania
Clinica de Gastroenterologie si Hepatologie Recruiting
Timisoara, Romania
Sponsors and Collaborators
Societatea Romana de Ultrasonografie in Medicina si Biologie
Centrul de Cercetare in Gastroenterologie si Hepatologie, Craiova
Clinica de Gastroenterologie si Hepatologie, UMF Timisoara
Institutul Regional de Gastroenterologie-Hepatologie "prof.dr. Octavian Fodor", Cluj-Napoca
Institutul Clinic Fundeni, Bucuresti
Clinica de Gastroenterologie Constanta
  More Information

Additional Information:
Publications:

Responsible Party: Socaciu Mihai, Societatea Romana de Ultrasonogragrafie in Medicina si Biologie
ClinicalTrials.gov Identifier: NCT01329458     History of Changes
Other Study ID Numbers: HepFocUS
Study First Received: April 2, 2011
Last Updated: April 5, 2011
Health Authority: Romania: National Authority for Scientific Research

Keywords provided by Societatea Romana de Ultrasonografie in Medicina si Biologie:
FLL
CEUS
SonoVue
HCC
Liver metastases
Hemangiomas
FNH

Additional relevant MeSH terms:
Focal Nodular Hyperplasia
Hyperplasia
Liver Diseases
Neoplasm Metastasis
Digestive System Diseases
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014