Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis (CHIC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Hospital, Angers.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00848952
First received: February 20, 2009
Last updated: February 3, 2010
Last verified: February 2009

February 20, 2009
February 3, 2010
March 2009
March 2010   (final data collection date for primary outcome measure)
Report of proportion of the positives truths and the positive wrong for an examination [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00848952 on ClinicalTrials.gov Archive Site
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Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis
Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis

The purpose of this study is to evaluate 3 imaging techniques and their associations : MRI, CTscanner and enhanced contrast ultrasound for the diagnosis of small (< 3 cm) hepatocellular carcinoma for patients with cirrhosis.

With the improvement of cirrhosis complications coverage, hepatocellular carcinoma (HCC) tend to become the main cause of mortality for cirrhotic patients. Currently, the incidence of the HCC increase in occidental country and hid global prognostic remain very bad. The main indication factor for a curative treatment is the size lesion.

Cirrhosis is the main risk factor for HCC occurence. In France, HCC screening has been establish for cirrhotic patients with hepatic ultrasound and alfa-fetoprotein measurement with the aim of detected HCC when the size allows a curative treatment.

When a nodule is discovered during the follow-up, HCC diagnosis is done following the recommendations of European Association for the Study of the Liver (AESL) in 2000, updated by the American Association for the Study of Liver Diseases (AASLD)in 2005. Diagnostic is function of nodule feature on one or two enhanced imaging techniques among CTscanner, MRI and enhanced contrast ultrasound.

This diagnostic strategy raises several questions. First, neither the most efficient dynamic imaging association for nodules from 1 to 2 cm, nor the most efficient imaging examination for nodules from 2 to 3 cm are known. Second, only few studies have been carried out about imaging semiology of the small hepatocellular carcinoma. Thus, the imprecisions of the present recommendations regarding the choice of the best examination technique and the difficulties in the diagnosis of benign or malignant nature for small nodule can lead to a bad management of these patients.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Hepatocellular Carcinoma
Other: 3 imaging techniques are done
all patients have : MRI, CTscanner, enhanced contrast ultrasound
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
450
Not Provided
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age > 18 hears
  • presence of one or several nodules < 3 cm
  • known or suspected cirrhosis

Exclusion Criteria:

  • psychiatric disease
  • contraindication to one of the 3 imaging examinations (CTscanner, MRI, enhanced contrast ultrasound
  • patient already treated by chemoembolization
  • recurrence on the coagulation zone of a nodule already treated by per-cutaneous tumour destruction
  • presence of a tumour (> 3 cm) associated to the nodule
  • pregnant woman or breast-feeding woman
Both
18 Years and older
No
Contact: Christophe Aube, professor 33-(0)2-41-35-42-81 chaube@chu-angers.fr
France
 
NCT00848952
PHRC 2008-01
Not Provided
Christophe Aubé, University Hospital Angers
University Hospital, Angers
Not Provided
Not Provided
University Hospital, Angers
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP