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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00682409
Enrollment
37
Registered
2008-05-22
Start date
2008-01-31
Completion date
2011-04-30
Last updated
2014-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholesteatoma

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.

Interventions

OTHERMR Imaging

MR imaging in the post operative follow-up of cholesteatoma in children

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 operation24 months

Secondary

MeasureTime frame
Only a surgical operation will confirm the diagnosis of cholesteatoma doing it again or residual.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.24 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026