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Diffusion Weighted MRI Accuracy in Cholesteatoma Localization (CHOLEMRI)

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ClinicalTrials.gov Identifier: NCT03915392
Recruitment Status : Recruiting
First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief 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

Condition or disease
Cholesteatoma

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Diffusion Weighted MRI Accuracy in Cholesteatoma Localization
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight




Primary Outcome Measures :
  1. MRI imaging study to locate cholesteatoma. [ Time Frame: The period from January 1st, 2010 to Dcember 31, 2017 will be examined ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent cholesteatoma surgery between January 1, 2010 and December 31, 2017
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915392


Contacts
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Contact: Anne CHARPIOT, MD, PhD 33 3 88 12 76 49 anne.charpiot@chru-strasbourg.fr
Contact: Antoine MERANGER, MD 33 3 88 12 76 49 antoine.meranger@chru-strasbourg.fr

Locations
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France
Service D'Orl Et de Chirurgie Cervico-Faciale Recruiting
Strasbourg, France, 67091
Contact: Anne CHARPIOT, MD, PhD    33 3 88 12 76 49    anne.charpiot@chru-strasbourg.fr   
Contact: Antoine MERANGER, MD    33 3 88 12 76 49    antoine.meranger@chru-strasbourg.fr   
Principal Investigator: Anne CHARPIOT, MD, PhD         
Sub-Investigator: Antoine MERANGER, MD         
Sub-Investigator: Francis VEILLON, MD, PhD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Study Director: Anne CHARPIOT, MD, PhD University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03915392     History of Changes
Other Study ID Numbers: 7122
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Strasbourg, France:
Diffusion weighted MRI
Cholesteatoma
Localization

Additional relevant MeSH terms:
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Body Weight
Cholesteatoma
Signs and Symptoms
Keratosis
Skin Diseases