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

NCT00682409 | Completed

• 2 other identifiers: 2007-A00743-502007-22
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholesteatoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (1)

1

OTHER

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

Interventions

MR Imaging OTHER

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

1

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

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

Marseille, 13005, France

Location

MeSH Terms

Conditions

Cholesteatoma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Brigitte BOURLIERE NAJEAN, MD

  Assistance Publique des Hôpitaux de Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 22, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 28, 2014

Record last verified: 2014-08

Locations

FR (1)