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

Hepatocellular Carcinoma Clinical Trial

— CHIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00848952
• Other study ID #: PHRC 2008-01
• Status: Not yet recruiting
• Phase: N/A
• First received: February 20, 2009
• Last updated: February 3, 2010
• Start date: March 2009

Study information

• Verified date: February 2009
• Source: University Hospital, Angers
• Contact: Christophe Aube, professor
• Phone: 33-(0)2-41-35-42-81
• Email: chaube[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Hôpital Saint-André	Bordeaux
France	Chu	Caen
France	hôpital Beaujon	Clichy
France	hôpital Henri Mondor	Créteil
France	Hôpital Du Bocage	Dijon
France	CHU	Grenoble
France	Hôpital de la croix rousse	Lyon
France	Hôpital E. Herriot	Lyon
France	Hôpital Saint Éloi	Montpellier
France	Hôpital Brabois	Nancy
France	Hôpital Hôtel Dieu	Nantes
France	hôpital archet II	Nice
France	Hôpital Saint Antoine	Paris
France	Hôpital Haut-Lévèque	Pessac
France	Hôpital Pontchaillou	Rennes
France	Hôpital Nord	Saint Étienne
France	Hôpital Paul Brousse	Villejuif
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Report of proportion of the positives truths and the positive wrong for an examination		one year	Yes