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

Primary Purpose

Cholesteatoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MR Imaging
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cholesteatoma

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

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

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
May 16, 2008
Last Updated
August 27, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT00682409
Brief Title
Magnetic Resonance (MR) Imaging in the Post Operative Follow-up of Cholesteatoma in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholesteatoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
MR Imaging
Intervention Description
MR imaging in the post operative follow-up of cholesteatoma in children
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Only a surgical operation will confirm the diagnosis of cholesteatoma doing it again or residual.
Time Frame
24 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte BOURLIERE NAJEAN, MD
Organizational Affiliation
Assistance Publique des Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de la Timone- Service de radiologie pédiatrique et d'ORL pédiatrique
City
Marseille
ZIP/Postal Code
13005
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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