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
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Usefulness of Non EPI-DWI-MRI / CT 3D Static Co-registration Prior to Surgery of Cholesteatomas|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||March 2018|
- 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 ]
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): NCT02903550
|Contact: Arthur VAROQUAUXfirstname.lastname@example.org|
|Hôpital de La Timone - Assistance Publique Hôpitaux de Marseille||Recruiting|
|Marseille Cedex 05, France, 13385|
|Contact: Arthur VAROQUAUX email@example.com|
|Study Director:||Urielle DESALBRES||Assistance Publique Hôpitaux de Marseille|