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Completed

NCT Number: NCT00682409

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

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.

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Key information

Conditions

Cholesteatoma Keratosis Skin Diseases Skin and Connective Tissue Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de la Timone- Service de radiologie pédiatrique et d'ORL pédiatrique

Marseille, 13005, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR Imaging

Other

MR imaging in the post operative follow-up of cholesteatoma in children

Primary outcomes

  1. 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

Secondary outcomes

  1. Only a surgical operation will confirm the diagnosis of cholesteatoma doing it again or residual.

    Time frame: 24 months

  2. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 22, 2008
Registry last updated
Aug 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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