Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis (CHIC)
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3 imaging techniques are done
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma
Eligibility 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
Sites / Locations
- CHU Angers
- Hôpital Saint-André
- Chu
- hôpital Beaujon
- hôpital Henri Mondor
- Hôpital Du Bocage
- CHU
- Hôpital de la croix rousse
- Hôpital E. Herriot
- Hôpital Saint Éloi
- Hôpital Brabois
- Hôpital Hôtel Dieu
- hôpital archet II
- Hôpital Saint Antoine
- Hôpital Haut-Lévèque
- Hôpital Pontchaillou
- Hôpital Nord
- Hôpital Paul Brousse
- Institut Gustave Roussy
Outcomes
Primary Outcome Measures
Report of proportion of the positives truths and the positive wrong for an examination
Secondary Outcome Measures
Full Information
NCT ID
NCT00848952
First Posted
February 20, 2009
Last Updated
February 3, 2010
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT00848952
Brief Title
Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis
Acronym
CHIC
Official Title
Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Angers
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
3 imaging techniques are done
Intervention Description
all patients have : MRI, CTscanner, enhanced contrast ultrasound
Primary Outcome Measure Information:
Title
Report of proportion of the positives truths and the positive wrong for an examination
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Aube, professor
Phone
33-(0)2-41-35-42-81
Email
chaube@chu-angers.fr
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aubé Christophe
Email
chaube@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Aubé Christophe
Facility Name
Hôpital Saint-André
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trillaud
Email
herve.trillaud@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Trillaud
Facility Name
Chu
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Le Pennec
Email
lepennec-v@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Le Pennec
Facility Name
hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vilgrain
Email
valerie.vilgrain@bjn.aphp.fr
First Name & Middle Initial & Last Name & Degree
Valérie Vilgrain
Facility Name
hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciani
Email
alain.luciani@hmn.aphp.fr
First Name & Middle Initial & Last Name & Degree
Luciani
Facility Name
Hôpital Du Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krause
Email
denis.krause@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Krause
Facility Name
CHU
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bricault
Email
IBricault@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Bricault
Facility Name
Hôpital de la croix rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rode
Email
agnes.rode@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Rode
Facility Name
Hôpital E. Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilleul
Email
frank.pilleul@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Pilleul
Facility Name
Hôpital Saint Éloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gallix
Email
b-gallix@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Gallix
Facility Name
Hôpital Brabois
City
Nancy
ZIP/Postal Code
54500
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent
Email
v.laurent@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Laurent
Facility Name
Hôpital Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dupas
Email
benoit.dupas@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Dupas
Facility Name
hôpital archet II
City
Nice
ZIP/Postal Code
06003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chevallier
Email
chevallier.p@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Chevallier
Facility Name
Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lewin
Email
maite.lewin@sat.aphp.fr
First Name & Middle Initial & Last Name & Degree
Lewin
Facility Name
Hôpital Haut-Lévèque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Drouillard
Email
jacques.drouillard@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Drouillard
Facility Name
Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivie
Email
damien.olivie@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Olivie
Facility Name
Hôpital Nord
City
Saint Étienne
ZIP/Postal Code
42055
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cuilleron
Email
muriel.cuilleron@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Cuilleron
Facility Name
Hôpital Paul Brousse
City
Villejuif
ZIP/Postal Code
94804
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bellin
Email
marie-france.bellin@bct.aphp.fr
First Name & Middle Initial & Last Name & Degree
Bellin
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dromain
Email
dromain@igr.fr
First Name & Middle Initial & Last Name & Degree
Dromain
12. IPD Sharing Statement
Citations:
PubMed Identifier
31870951
Citation
Paisant A, Vilgrain V, Riou J, Oberti F, Sutter O, Laurent V, Rodes A, Guiu B, Cassinotto C, Trillaud H, Bricault I, Michalak S, Bruno O, Ronot M, Aube C. Comparison of extracellular and hepatobiliary MR contrast agents for the diagnosis of small HCCs. J Hepatol. 2020 May;72(5):937-945. doi: 10.1016/j.jhep.2019.12.011. Epub 2019 Dec 21.
Results Reference
derived
PubMed Identifier
28346737
Citation
Aube C, Oberti F, Lonjon J, Pageaux G, Seror O, N'Kontchou G, Rode A, Radenne S, Cassinotto C, Vergniol J, Bricault I, Leroy V, Ronot M, Castera L, Michalak S, Esvan M, Vilgrain V; CHIC Group. EASL and AASLD recommendations for the diagnosis of HCC to the test of daily practice. Liver Int. 2017 Oct;37(10):1515-1525. doi: 10.1111/liv.13429. Epub 2017 Apr 26.
Results Reference
derived
Learn more about this trial
Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis
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