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
  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
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

Contacts
Contact: Christophe Aube, professor 33-(0)2-41-35-42-81 chaube@chu-angers.fr

Locations
France
CHU Angers Recruiting
Angers, France
Contact: Aubé Christophe       chaube@chu-angers.fr   
Principal Investigator: Aubé Christophe         
Hôpital Saint-André Not yet recruiting
Bordeaux, France, 33300
Contact: Trillaud       herve.trillaud@chu-bordeaux.fr   
Principal Investigator: Trillaud         
Chu Not yet recruiting
Caen, France, 14033
Contact: Le Pennec       lepennec-v@chu-caen.fr   
Principal Investigator: Le Pennec         
hôpital Beaujon Not yet recruiting
Clichy, France, 92110
Contact: Vilgrain       valerie.vilgrain@bjn.aphp.fr   
Principal Investigator: Valérie Vilgrain         
hôpital Henri Mondor Not yet recruiting
Créteil, France, 94010
Contact: Luciani       alain.luciani@hmn.aphp.fr   
Principal Investigator: Luciani         
Hôpital Du Bocage Not yet recruiting
Dijon, France, 21079
Contact: Krause       denis.krause@chu-dijon.fr   
Principal Investigator: Krause         
CHU Not yet recruiting
Grenoble, France, 38043
Contact: Bricault       IBricault@chu-grenoble.fr   
Principal Investigator: Bricault         
Hôpital E. Herriot Not yet recruiting
Lyon, France, 69437
Contact: Pilleul       frank.pilleul@chu-lyon.fr   
Principal Investigator: Pilleul         
Hôpital de la croix rousse Not yet recruiting
Lyon, France, 69317
Contact: Rode       agnes.rode@chu-lyon.fr   
Principal Investigator: Rode         
Hôpital Saint Éloi Not yet recruiting
Montpellier, France, 34295
Contact: Gallix       b-gallix@chu-montpellier.fr   
Principal Investigator: Gallix         
Hôpital Brabois Not yet recruiting
Nancy, France, 54500
Contact: Laurent       v.laurent@chu-nancy.fr   
Principal Investigator: Laurent         
Hôpital Hôtel Dieu Not yet recruiting
Nantes, France, 44093
Contact: Dupas       benoit.dupas@chu-nantes.fr   
Principal Investigator: Dupas         
hôpital archet II Not yet recruiting
Nice, France, 06003
Contact: Chevallier       chevallier.p@chu-nice.fr   
Principal Investigator: Chevallier         
Hôpital Saint Antoine Not yet recruiting
Paris, France, 75012
Contact: Lewin       maite.lewin@sat.aphp.fr   
Principal Investigator: Lewin         
Hôpital Haut-Lévèque Not yet recruiting
Pessac, France, 33604
Contact: Drouillard       jacques.drouillard@chu-bordeaux.fr   
Principal Investigator: Drouillard         
Hôpital Pontchaillou Not yet recruiting
Rennes, France, 35033
Contact: Olivie       damien.olivie@chu-rennes.fr   
Principal Investigator: Olivie         
Hôpital Nord Not yet recruiting
Saint Étienne, France, 42055
Contact: Cuilleron       muriel.cuilleron@chu-st-etienne.fr   
Principal Investigator: Cuilleron         
Hôpital Paul Brousse Not yet recruiting
Villejuif, France, 94804
Contact: Bellin       marie-france.bellin@bct.aphp.fr   
Principal Investigator: Bellin         
Institut Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Contact: Dromain       dromain@igr.fr   
Principal Investigator: Dromain         
Sponsors and Collaborators
University Hospital, Angers
  More Information

No publications provided

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
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 29, 2014