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Magnetic Resonance (MR) Imaging in the Post Operative Follow-up of Cholesteatoma in Children
This study is currently recruiting participants.
Verified by Assistance Publique Hopitaux De Marseille, January 2009
First Received: May 16, 2008   Last Updated: January 14, 2009   History of Changes
Sponsored by: Assistance Publique Hopitaux De Marseille
Information provided by: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00682409
  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: Diagnostic, Open Label, Uncontrolled, Single Group Assignment

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 ]

Estimated Enrollment: 50
Study Start Date: February 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: January 2009 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682409

Contacts
Contact: Brigitte BOURLIERE NAJEAN, MD 0491386797 bbourliere@ap-hm.fr
Contact: Jérôme DELATTRE, MD 0491296343 delattre.orl@wanadoo.fr

Locations
France
Hôpital de la Timone- Service de radiologie pédiatrique et d'ORL pédiatrique Recruiting
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 des Hôpitaux de Marseille ( Assistance Publique des Hôpitaux de Marseille )
Study ID Numbers: 2007-A00743-50, 2007-22
Study First Received: May 16, 2008
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00682409     History of Changes
Health Authority: France: Ministry of Health

Study placed in the following topic categories:
Keratosis
Skin Diseases
Cholesteatoma
Tylosis

Additional relevant MeSH terms:
Keratosis
Skin Diseases
Cholesteatoma

ClinicalTrials.gov processed this record on September 10, 2009