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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 20, 2009

Last Updated Date

February 3, 2010

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Report of proportion of the positives truths and the positive wrong for an examination [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00848952 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Hepatocellular Carcinoma

Intervention ^ICMJE

Other: 3 imaging techniques are done

all patients have : MRI, CTscanner, enhanced contrast ultrasound

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

450

Completion Date

Not Provided

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Christophe Aube, professor

33-(0)2-41-35-42-81

chaube@chu-angers.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00848952

Other Study ID Numbers ^ICMJE

PHRC 2008-01

Has Data Monitoring Committee

Not Provided

Responsible Party

Christophe Aubé, University Hospital Angers

Study Sponsor ^ICMJE

University Hospital, Angers

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

University Hospital, Angers

Verification Date

February 2009

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

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