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

Cholesteatoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682409
• Other study ID #: 2007-A00743-50
• Secondary ID: 2007-22
• Status: Completed
• Phase: N/A
• First received: May 16, 2008
• Last updated: August 27, 2014
• Start date: January 2008
• Est. completion date: April 2011

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cholesteatoma

Intervention

Other:
• MR Imaging
MR imaging in the post operative follow-up of cholesteatoma in children

Locations

Country	Name	City	State
France	Hôpital de la Timone- Service de radiologie pédiatrique et d'ORL pédiatrique	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		24 months	Yes
Secondary	Only a surgical operation will confirm the diagnosis of cholesteatoma doing it again or residual.		24 months	Yes
Secondary	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.		24 months	Yes