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
  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 ]

Estimated Enrollment: 50
Study Start Date: January 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
ClinicalTrials.gov Identifier: NCT00682409     History of Changes
Other Study ID Numbers: 2007-A00743-50, 2007-22
Study First Received: May 16, 2008
Last Updated: January 28, 2010
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Cholesteatoma
Keratosis
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014