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

NCT ID: NCT00682409

Last Updated: 2014-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-04-30

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.

Conditions

Cholesteatoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

MR Imaging

Intervention Type: OTHER

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

Interventions

MR Imaging

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brigitte BOURLIERE NAJEAN, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique des Hôpitaux de Marseille

Locations

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

Marseille, , France

Countries

France

Other Identifiers

2007-22

Identifier Type: -

Identifier Source: secondary_id

2007-A00743-50

Identifier Type: -

Identifier Source: org_study_id