Cone Beam CT Versus Multislice CT in the Postoperative Assessment of Cochlear Implantation (COCOBE)

Cone Beam CT Versus Multislice CT: Radiologic Diagnostic Agreement in the Postoperative Assessment of Cochlear Implantation

Objective: To evaluate the diagnostic concordance between multislice computed tomography (MSCT) and cone beam computed tomography (CBCT) in the early postoperative assessment of patients after cochlear implantation.

Study Design: Prospective, randomized, single-center, interventional, pilot study on the diagnostic performance of a medical device.

Setting: Tertiary referral center. Patients: Patients aged over 18 years requiring a CT scan after cochlear implant surgery.

Interventions: Nine patients were implanted with electrode arrays from three different manufacturers, including one bilateral. High-resolution MSCT and CBCT were then performed, and 2 experienced radiologists blinded to the imaging modality evaluated the randomized images, twice.

Study Overview

• Status: Completed
• Conditions: Cochlear Implants
• Intervention / Treatment: Radiation: Cone Beam Computed Tomography (CBCT); Radiation: Multiple Detector Computed Tomography (MDCT)

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Service imagerie pavillon B, Hopital E. Herriot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• CI surgery for severe to profound bilateral deafness
• affiliated with the French health insurance

Exclusion Criteria:

• pregnancy
• Patients weighing more than 160 kg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cone Beam; Patients included will have first a MultiSlice Computed tomography (MSCT) as usual and then a Cone Beam Computed Tomography (CBCT)	Radiation: Cone Beam Computed Tomography (CBCT); Patients had an additional Cone Beam Computed Tomography, after the usual MDCT; Radiation: Multiple Detector Computed Tomography (MDCT); Patients had a usual MDCT, before having an additional Cone Beam Computed Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance between MDCT and CBCT for assessing the scalar position of the electrodes	Blinded images were analyzed in random order by 2 radiologists with several years of experience in temporal bone imaging. Each radiologist analyzed on the workstation the images of each patient twice at 4- to 8-week intervals. A consensus reading was performed by a third experienced radiologist in case of discordance. Each radiologist determined CI localization. The cochlear implant (CI) was considered within the scala tympani if it was in the most posterior scala on axial reconstructions passing through the cochlea (behind the osseous spiral lamina often seen).	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of the intracochlear electrode array	Blinded images were analyzed in random order by 2 radiologists with several years of experience in temporal bone imaging. Each radiologist analyzed on the workstation the images of each patient twice at 4- to 8-week intervals. A consensus reading was performed by a third experienced radiologist in case of discordance. This measurement was performed in the oblique coronal plane of the cochlea.	At inclusion
percentage of implanted cochlea	Blinded images were analyzed in random order by 2 radiologists with several years of experience in temporal bone imaging. Each radiologist analyzed on the workstation the images of each patient twice at 4- to 8-week intervals. A consensus reading was performed by a third experienced radiologist in case of discordance. This measurement was performed in the oblique coronal plane of the cochlea.	At inclusion
number of intracochlear electrodes	Blinded images were analyzed in random order by 2 radiologists with several years of experience in temporal bone imaging. Each radiologist analyzed on the workstation the images of each patient twice at 4- to 8-week intervals. A consensus reading was performed by a third experienced radiologist in case of discordance. This measurement was performed in the oblique coronal plane of the cochlea.	At inclusion
radiation dose	Radiation dose was estimated using Computed Tomography Dose Index (CTDI, in Gy.cm) for each patient and scanner. These data are collected directly from the data sheet for each examination (also anonymised).	At inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• Razafindranaly V, Truy E, Pialat JB, Martinon A, Bourhis M, Boublay N, Faure F, Ltaief-Boudrigua A. Cone Beam CT Versus Multislice CT: Radiologic Diagnostic Agreement in the Postoperative Assessment of Cochlear Implantation. Otol Neurotol. 2016 Oct;37(9):1246-54. doi: 10.1097/MAO.0000000000001165.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 2, 2016
• First Submitted That Met QC Criteria: September 2, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2012.736

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No