NCT00848952

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

19 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

February 4, 2010

Status Verified

February 1, 2009

Enrollment Period

1 year

First QC Date

February 20, 2009

Last Update Submit

February 3, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Report of proportion of the positives truths and the positive wrong for an examination

    one year

Interventions

all patients have : MRI, CTscanner, enhanced contrast ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 hears
  • presence of one or several nodules \< 3 cm
  • known or suspected cirrhosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

CHU Angers

Angers, France

Location

Hôpital Saint-André

Bordeaux, 33300, France

Location

Chu

Caen, 14033, France

Location

hôpital Beaujon

Clichy, 92110, France

Location

hôpital Henri Mondor

Créteil, 94010, France

Location

Hôpital Du Bocage

Dijon, 21079, France

Location

CHU

Grenoble, 38043, France

Location

Hôpital de la croix rousse

Lyon, 69317, France

Location

Hôpital E. Herriot

Lyon, 69437, France

Location

Hôpital Saint Éloi

Montpellier, 34295, France

Location

Hôpital Brabois

Nancy, 54500, France

Location

Hôpital Hôtel Dieu

Nantes, 44093, France

Location

hôpital archet II

Nice, 06003, France

Location

Hôpital Saint Antoine

Paris, 75012, France

Location

Hôpital Haut-Lévèque

Pessac, 33604, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Hôpital Nord

Saint-Etienne, 42055, France

Location

Hôpital Paul Brousse

Villejuif, 94804, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Christophe Aube, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 20, 2009

First Posted

February 23, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Last Updated

February 4, 2010

Record last verified: 2009-02

Locations