- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00682409
Magnetic Resonance (MR) Imaging in the Post Operative Follow-up of Cholesteatoma in Children
August 27, 2014 updated by: Assistance Publique Hopitaux De Marseille
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Marseille, France, 13005
- Hôpital de la Timone- Service de radiologie pédiatrique et d'ORL pédiatrique
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
|
MR imaging in the post operative follow-up of cholesteatoma in children
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Only a surgical operation will confirm the diagnosis of cholesteatoma doing it again or residual.
Time Frame: 24 months
|
24 months
|
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
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Brigitte BOURLIERE NAJEAN, MD, Assistance Publique des Hôpitaux de Marseille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
May 16, 2008
First Submitted That Met QC Criteria
May 20, 2008
First Posted (Estimate)
May 22, 2008
Study Record Updates
Last Update Posted (Estimate)
August 28, 2014
Last Update Submitted That Met QC Criteria
August 27, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-A00743-50
- 2007-22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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