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Status unknownNCT00848952CHICUpdated Feb 4, 2010

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

An interventional study of 3 imaging techniques are done in Hepatocellular Carcinoma, sponsored by University Hospital, Angers. Status unknown at 19 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-02-04.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
450
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hepatocellular Carcinoma
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In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's planned enrollment of 450 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
450 participants (estimated)

Interventions

  • Other3 imaging techniques are done

    all patients have : MRI, CTscanner, enhanced contrast ultrasound

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What researchers measure

Primary outcomes

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

    Time frame: one year

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Study locations

19 sites
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References and documents

Publications

  • 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. PubMed 31870951 ↗
  • 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. PubMed 28346737 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00848952
Lead sponsor
University Hospital, Angers
First posted
Feb 23, 2009
Start date
Mar 2009
Primary completion
Mar 2010 (estimated)
Last update
Feb 4, 2010

Study contacts

Christophe Aube, professor
Contact
chaube@chu-angers.fr
33-(0)2-41-35-42-81
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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