Effect of Implant Position on Magnetic Resonance Image Distortion
Primary Purpose
Neurofibromatosis Type 2
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MR imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Neurofibromatosis Type 2
Eligibility Criteria
Inclusion Criteria:
- Any patient over the age of 18 with NF2 who has an auditory implant (cochlear or auditory brainstem implant) in situ and requires MRI scanning.
Exclusion Criteria:
Children under the age of 18 years Claustrophobia Bilateral implants
Contraindications and relative contraindications for MRI (as per the Radiology Department MRI protocol) including:
Pacemaker Certain metallic heart valves Ferromagnetic implanted materials and foreign bodies
Sites / Locations
- Central Manchester University Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NF2 who has an auditory implant
Arm Description
Outcomes
Primary Outcome Measures
To study the effect of magnet orientation in auditory brainstem implants/ cochlear implants in determining the size of signal void seen on MRI scanning.
Secondary Outcome Measures
To identify if there is an angle at which the signal void is minimised
Full Information
NCT ID
NCT02246231
First Posted
September 18, 2014
Last Updated
March 16, 2020
Sponsor
Manchester University NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02246231
Brief Title
Effect of Implant Position on Magnetic Resonance Image Distortion
Official Title
The Effect of Changes in Head Position on Magnetic Resonance Image Distortion in Patients With Auditory Implants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 3, 2014 (Actual)
Primary Completion Date
January 31, 2015 (Actual)
Study Completion Date
January 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with Neurofibromatosis type 2 (NF2) almost always develop acoustic neuromas in both ears. As a result of the tumours themselves or the treatment of the tumours, many patients become profoundly deaf in both ears. It is possible to restore a degree of hearing by placing a hearing implant in the brainstem adjacent to the hearing pathways within the brain. This is termed an auditory brainstem implant (ABI).
The aim of this study is to find the optimum head position in relation to the MRI magnet field, which would produce least area of image distortion in patients with ABIs. This will be of benefit in optimising the MR imaging in future patients with implants.
Detailed Description
Auditory brainstem implants (ABI) are placed against the auditory centres in the brainstem if it is not possible to implant the cochlea or if the cochlear nerve, which conveys neural signals from the cochlea to the brainstem, is damaged or absent. The latter device is usually used in patients with Neurofibromatosis type 2 (NF2) who develop bilateral benign inner ear tumours called vestibular schwannomas as well as other neurological tumours1. These patients often become bilaterally profoundly deaf either as a result of the disease or because of surgery to remove the tumours and require an ABI.
Patients with NF2 require monitoring of their tumours. In the absence of an auditory implant it is possible to use magnetic resonance imaging. This is the gold standard imaging technique as it gives excellent views of the soft tissues of head. However, there has been concern regarding the use of MRI in patients with auditory implants until recently because of potential problems such as demagnetisation of the magnet within the implant, implant magnet displacement and risk to the integrity of the implant electronics. In addition, the magnet field of the implant magnet results in imaging artefact (manifesting as a signal void) around the implant site that limits the information that can be obtained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofibromatosis Type 2
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NF2 who has an auditory implant
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MR imaging
Primary Outcome Measure Information:
Title
To study the effect of magnet orientation in auditory brainstem implants/ cochlear implants in determining the size of signal void seen on MRI scanning.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To identify if there is an angle at which the signal void is minimised
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Any patient over the age of 18 with NF2 who has an auditory implant (cochlear or auditory brainstem implant) in situ and requires MRI scanning.
Exclusion Criteria:
Children under the age of 18 years Claustrophobia Bilateral implants
Contraindications and relative contraindications for MRI (as per the Radiology Department MRI protocol) including:
Pacemaker Certain metallic heart valves Ferromagnetic implanted materials and foreign bodies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Lloyd
Organizational Affiliation
Manchester University NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Manchester University Hospitals NHS Foundation Trust
City
Manchester
State/Province
Manchester (Manchester Borough)
ZIP/Postal Code
M13 9WL
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Effect of Implant Position on Magnetic Resonance Image Distortion
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