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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00848952
Recruitment Status : Unknown
Verified February 2009 by University Hospital, Angers.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2009
Last Update Posted : February 4, 2010
Information provided by:
University Hospital, Angers

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Other: 3 imaging techniques are done Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis
Study Start Date : March 2009
Estimated Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Other: 3 imaging techniques are done
    all patients have : MRI, CTscanner, enhanced contrast ultrasound

Primary Outcome Measures :
  1. Report of proportion of the positives truths and the positive wrong for an examination [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00848952

Contact: Christophe Aube, professor 33-(0)2-41-35-42-81

CHU Angers Recruiting
Angers, France
Contact: Aubé Christophe   
Principal Investigator: Aubé Christophe         
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Principal Investigator: Dupas         
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Principal Investigator: Chevallier         
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Contact: Lewin   
Principal Investigator: Lewin         
Hôpital Haut-Lévèque Not yet recruiting
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Contact: Drouillard   
Principal Investigator: Drouillard         
Hôpital Pontchaillou Not yet recruiting
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Contact: Olivie   
Principal Investigator: Olivie         
Hôpital Nord Not yet recruiting
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Contact: Cuilleron   
Principal Investigator: Cuilleron         
Hôpital Paul Brousse Not yet recruiting
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Principal Investigator: Bellin         
Institut Gustave Roussy Not yet recruiting
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Contact: Dromain   
Principal Investigator: Dromain         
Sponsors and Collaborators
University Hospital, Angers

Responsible Party: Christophe Aubé, University Hospital Angers Identifier: NCT00848952     History of Changes
Other Study ID Numbers: PHRC 2008-01
First Posted: February 23, 2009    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2009

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases