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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  Purpose
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 Intervention
Hepatocellular Carcinoma
Other: 3 imaging techniques are done

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

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

Estimated Enrollment: 450
Study Start Date: March 2009
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: 3 imaging techniques are done
    all patients have : MRI, CTscanner, enhanced contrast ultrasound
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848952

Locations
France
CHU Angers
Angers, France
Hôpital Saint-André
Bordeaux, France, 33300
Chu
Caen, France, 14033
hôpital Beaujon
Clichy, France, 92110
hôpital Henri Mondor
Créteil, France, 94010
Hôpital Du Bocage
Dijon, France, 21079
CHU
Grenoble, France, 38043
Hôpital de la croix rousse
Lyon, France, 69317
Hôpital E. Herriot
Lyon, France, 69437
Hôpital Saint Éloi
Montpellier, France, 34295
Hôpital Brabois
Nancy, France, 54500
Hôpital Hôtel Dieu
Nantes, France, 44093
hôpital archet II
Nice, France, 06003
Hôpital Saint Antoine
Paris, France, 75012
Hôpital Haut-Lévèque
Pessac, France, 33604
Hôpital Pontchaillou
Rennes, France, 35033
Hôpital Nord
Saint Étienne, France, 42055
Hôpital Paul Brousse
Villejuif, France, 94804
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
University Hospital, Angers
  More Information

Responsible Party: Christophe Aubé, University Hospital Angers
ClinicalTrials.gov Identifier: NCT00848952     History of Changes
Other Study ID Numbers: PHRC 2008-01 
Study First Received: February 20, 2009
Last Updated: February 3, 2010
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on December 09, 2016