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

Cholesteatoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02903550
• Other study ID #: 2015-27
• Status: Recruiting
• Phase: N/A
• First received: September 13, 2016
• Last updated: March 12, 2018
• Start date: August 2015
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Arthur VAROQUAUX
• Email: arthur.varoquaux[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Chronic renal failure

• Contraindications to MRI

Related Conditions & MeSH terms

• Cholesteatoma

Locations

Country	Name	City	State
France	Hôpital de La Timone - Assistance Publique Hôpitaux de Marseille	Marseille Cedex 05

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the lesion on the scanner with the help of MRI, but without having merged both methods		UP to 18 months
Primary	Measure of the lesion volume in mm3		Up to 18 months