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

University Hospital, Angers

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Other: 3 imaging techniques are done

Study type: Interventional

Funder types: Other

Identifiers

NCT00848952

PHRC 2008-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)