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Usefulness of Non EPI-DWI-MRI / CT 3D Static Co-registration Prior to Surgery of Cholesteatomas

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ClinicalTrials.gov Identifier: NCT02903550
Recruitment Status : Unknown
Verified March 2018 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : September 16, 2016
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date September 13, 2016
First Posted Date September 16, 2016
Last Update Posted Date March 13, 2018
Study Start Date August 2015
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 15, 2016)
  • Determination of the lesion on the scanner with the help of MRI, but without having merged both methods [ Time Frame: UP to 18 months ]
  • Measure of the lesion volume in mm3 [ Time Frame: Up to 18 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Usefulness of Non EPI-DWI-MRI / CT 3D Static Co-registration Prior to Surgery of Cholesteatomas
Official Title Usefulness of Non EPI-DWI-MRI / CT 3D Static Co-registration Prior to Surgery of Cholesteatomas
Brief Summary

Cholesteatoma is a destructive and expanding pathologic condition consisting of keratin pearl arising from a squamous epithelium in the middle ear and/or mastoid process. Evolution consists in a destruction of the ossicles as well as their possible spread through the base of the skull into the brain. Surgical treatment is required to prevent infectious or functional complications. A recurrence after surgery occurs in approximately 10% of patients and rarely affects initial site. Surgical treatment is the only care option for recurrent cholesteatoma. Various locations such as surgical approach cavity, mastoid, hypotympanum are seen. Temporal bone CT is performed prior to surgery for added information on bone erosions especially of ossicules, tegmen tympani, facial nerve canal of internal ear. Due high anatomical resolution and complex anatomy, temporal bone CT is usually displayed with Magnetic Resonance Imaging (MRI) in operating room to help surgical guidance .

Imaging especially using MRI is the cornerstone for diagnosis in asymptomatic patients. Since 2006, non echo planar imaging (EPI) Diffusion weighted imaging (DWI) Magnetic resonance imaging (MRI) (sequences has shown high accuracy to depict recurrent cholesteatoma. If EPI sequences had a high rate of diffeomorphic atefacts whereas non EPI sequences using either HAlf-Fourier acquisition Single-shot Turbo spin-Echo (HASTE) or Fast-spin-echo demonstrates less magnetic susceptibility artifacts. Multimodality fusion between NonEPI-DWI-MRI and computerized tomography (CT) is a rational promising tool to rise the performance for cholesteatomas delineation. The performances of NonEPI-DWI-MRI in assessing lesion spread and volume are still unknown and needs further investigations. The aim of the study is to assess the DWI-MRI/CT fusion feasibility, reproducibility and the accuracy prior to surgery propectively compared to surgical findings.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Patient who had surgery and suspicion of recurrence of cholesteatoma for whom it is prescribed:

  • MRI with diffusion through systematic monitoring after treatment of acquired cholesteatoma of the middle ear: between 12 and 18 months and 4 years
  • If positive MRI scanner producing a rock without injection in the preoperative assessment
Condition Cholesteatoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 15, 2016)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2018
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

- Adult woman or man who had surgery and suspicion of cholesteatoma recurrence

Exclusion Criteria:

  • Chronic renal failure
  • Contraindications to MRI
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02903550
Other Study ID Numbers 2015-27
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor Assistance Publique Hopitaux De Marseille
Collaborators Not Provided
Investigators
Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date March 2018