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

Not Applicable

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT00848952
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2009-02
• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-23
• Study Start: 2009-03
• Last Update Submitted: 2010-02-03
• Last Update Posted: 2010-02-04
• Primary Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Report of proportion of the positives truths and the positive wrong for an examination	one year

Trial Locations

Locations (19)

Hôpital Saint-André; 🇫🇷 Bordeaux, France

CHU Angers; 🇫🇷 Angers, France

Hôpital de la croix rousse; 🇫🇷 Lyon, France

Hôpital Saint Antoine; 🇫🇷 Paris, France

hôpital Beaujon; 🇫🇷 Clichy, France

Hôpital Du Bocage; 🇫🇷 Dijon, France

Hôpital E. Herriot; 🇫🇷 Lyon, France

Chu; 🇫🇷 Caen, France

CHU; 🇫🇷 Grenoble, France

hôpital Henri Mondor; 🇫🇷 Créteil, France

Hôpital Saint Éloi; 🇫🇷 Montpellier, France

Hôpital Brabois; 🇫🇷 Nancy, France

Hôpital Hôtel Dieu; 🇫🇷 Nantes, France

hôpital archet II; 🇫🇷 Nice, France

Hôpital Pontchaillou; 🇫🇷 Rennes, France

Hôpital Haut-Lévèque; 🇫🇷 Pessac, France

Hôpital Nord; 🇫🇷 Saint Étienne, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Hôpital Paul Brousse; 🇫🇷 Villejuif, France