Diffusion Weighted MRI Accuracy in Cholesteatoma Localization

Cholesteatoma Clinical Trial

— CHOLEMRI  

Official title:

Diffusion Weighted MRI Accuracy in Cholesteatoma Localization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03915392
• Other study ID #: 7122
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: July 2019

Study information

• Verified date: September 2018
• Source: University Hospital, Strasbourg, France
• Contact: Anne CHARPIOT, MD, PhD
• Phone: 33 3 88 12 76 49
• Email: anne.charpiot[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Magnetic resonance imaging of the middle ear has an increasing place in the therapeutic strategy in otology and especially for cholesteatoma. It is currently performed for complicated cholesteatomas and as part of the follow-up of operated patients to detect a recurrence or a cholesteatoma residue (alternative of choice to "second look" surgery). Some people take CT and MRI fusion to improve the localization of cholesteatoma. Many studies have investigated the diagnostic capabilities of MRI but very few have demonstrate their reliability in location diagnosis. The aim of the study was to propose a topographic reading method of the MRI of the middle ear and to evaluate the performances in the localization of the cholesteatoma in order to adapt the surgical management

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

inclusion criteria

• Age: from 1 month and up

• Sex: man / woman

• Patient who had a tympanoplasty in closed technique, for the first surgical time of a cholesteatoma or for residual or recurrent cholesteatoma, performed by the same radiologist (Pr Anne Charpiot) with the following characteristics:

• Code of the Common Classification of Medical Acts (CCAM)

• Exeresis of cholesteatoma with tympanoplasty in closed technique and ossiculoplasty (CBFA002)

• Exeresis of cholesteatoma with tympanoplasty in closed technique (CBFA006)

• Exeresis of cholesteatoma confined to the tympanic cavity without antro-attic exploration (CBFA005)

• Tympanoplasty in closed technique with posterior tympanotomy (CBMD001)

• Secondary tympanoplasty in closed technique (CBMD002)

• Diagnostic code of the International Classification of Diseases (ICD10)

• Cholesteatoma of the middle ear (H71)

• Diagnosis of macroscopic and / or pathological cholesteatoma.

• Preoperative diagnosis of cholesteatoma on MRI of the middle ear performed in less than 6 months by the same radiologist (Pr Francis Veillon).

• Subject (or the holders of parental authority in the case of minors) having agreed to the use of medical data for the purpose of this research.

Cholesteatoma is a very common disease in the pediatric population, with important functional issues, whose treatment is surgical. That's why our study includes minor subjects.

Criteria of non-inclusion

• Refusal of the patient to participate in the study

• Absence of data concerning the diagnosis and / or localization of cholesteatoma on the operative record

• Subject under the protection of justice

• Subject under guardianship or curatorship

• Pregnancy (woman of childbearing age)

• Breastfeeding

Related Conditions & MeSH terms

• Body Weight
• Cholesteatoma

Locations

Country	Name	City	State
France	Service D'Orl Et de Chirurgie Cervico-Faciale	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI imaging study to locate cholesteatoma.		The period from January 1st, 2010 to Dcember 31, 2017 will be examined