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

NCT02903550 | Unknown

• 1 other identifier: 2015-27
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholesteatoma

Outcome Measures

Primary Outcomes (2)

• Determination of the lesion on the scanner with the help of MRI, but without having merged both methods

  UP to 18 months

• Measure of the lesion volume in mm3

  Up to 18 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Chronic renal failure
• Contraindications to MRI

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Hôpital de La Timone - Assistance Publique Hôpitaux de Marseille

Marseille, 13385, France

RECRUITING

MeSH Terms

Conditions

Cholesteatoma

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Urielle DESALBRES

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Arthur VAROQUAUX

CONTACT

arthur.varoquaux@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: August 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: March 1, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

FR (1)