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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00682409
First received: May 16, 2008
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Cholesteatoma
Other: MR Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: January 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: MR Imaging
MR imaging in the post operative follow-up of cholesteatoma in children

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00682409

Locations
France
Hôpital de la Timone- Service de radiologie pédiatrique et d'ORL pédiatrique
Marseille, France, 13005
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Brigitte BOURLIERE NAJEAN, MD Assistance Publique des Hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00682409     History of Changes
Other Study ID Numbers: 2007-A00743-50, 2007-22
Study First Received: May 16, 2008
Last Updated: August 27, 2014
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Cholesteatoma
Keratosis
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014