Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis (CHIC)
Recruitment status was Not yet recruiting
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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 |
- 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) |
-
Other: 3 imaging techniques are done
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 |
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| Contact: Christophe Aube, professor | 33-(0)2-41-35-42-81 | chaube@chu-angers.fr |
| 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 | |
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 Fibrosis Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pathologic Processes |
Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 23, 2013