Magnetic Resonance (MR) Imaging in the Post Operative Follow-up of Cholesteatoma in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00682409
First received: May 16, 2008
Last updated: January 28, 2010
Last verified: January 2010

May 16, 2008
January 28, 2010
January 2008
July 2011   (final data collection date for primary outcome measure)
Technical characteristics of the examination MRIs represented by the sensibility and the specificity of the test, with regard to the results stemming from the surgical operation [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00682409 on ClinicalTrials.gov Archive Site
  • Only a surgical operation will confirm the diagnosis of cholesteatoma doing it again or residual. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • It is necessary to test the following diagnostic method: the analysis of the morphological sequences in T1 and in T2 will allow to appreciate the existence or not of a filling of the cavity tympanique or the mastoïde and to clarify its localization. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Magnetic Resonance (MR) Imaging in the Post Operative Follow-up of Cholesteatoma in Children
Not Provided

Classical imaging techniques are inaccurate to detect residual cholesteatoma. The aim of our study is to evaluate the value of diffusion-weighted MR imaging and delayed contrast enhanced T1 weighted spin-echo sequences in the detection of residual cholesteatoma in children, in a large serie of surgically verified cases.

Classical imaging techniques are inaccurate to detect residual cholesteatoma. Thin-section CT detects that the postoperative cavity is filled with a soft tissue mass. Classical MR imaging (T2 and T1 weighted spin-echo sequences) can not provide additionnal information about the nature of this filling : cholesteatoma, granulation or fibrous tissue.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cholesteatoma
Other: MR Imaging
MR imaging in the post operative follow-up of cholesteatoma in children
1
Analysis of the value of the imaging of distribution and the late sequence to differentiate the cholesteatoma of the fibrosis in the follow-up operating post at the child
Intervention: Other: MR Imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2012
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female or male child enters 5 and 18 years
  • Child having benefited from a surgical operation for cholesteatoma of the average ear acquired or congenital, one-sided or bilateral
  • Child for whom an additional operating time is indicated
  • Child without contraindication in the MRI
  • Child having signed a enlightened assent
  • Child among whom the parents or the legal representatives signed a enlightened assent

Exclusion Criteria:

  • Child of less than 5 years old and more than 18 years
  • Child presenting a chronic renal insufficiency
  • Child for whom an additional operating time is not indicated
  • Child having a contraindication in the MRI
  • Child not having signed the assent or the parents of which did not sign the assent
Both
5 Years to 18 Years
No
Contact: Brigitte BOURLIERE NAJEAN, MD 0491386797 bbourliere@ap-hm.fr
Contact: Jérôme DELATTRE, MD 0491296343 delattre.orl@wanadoo.fr
France
 
NCT00682409
2007-A00743-50, 2007-22
No
Assistance Publique des Hôpitaux de Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: Brigitte BOURLIERE NAJEAN, MD Assistance Publique des Hôpitaux de Marseille
Assistance Publique Hopitaux De Marseille
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP