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Effect of Implant Position on Magnetic Resonance Image Distortion

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Hayley Brooks, Central Manchester University Hospitals NHS Foundation Trust.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02246231
First Posted: September 22, 2014
Last Update Posted: September 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hayley Brooks, Central Manchester University Hospitals NHS Foundation Trust
  Purpose

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.


Condition Intervention
Neurofibromatosis Type 2 Device: MR imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effect of Changes in Head Position on Magnetic Resonance Image Distortion in Patients With Auditory Implants

Resource links provided by NLM:


Further study details as provided by Hayley Brooks, Central Manchester University Hospitals NHS Foundation Trust:

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. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • To identify if there is an angle at which the signal void is minimised [ Time Frame: 1 year ]

Estimated Enrollment: 12
Study Start Date: November 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NF2 who has an auditory implant Device: MR imaging

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

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): NCT02246231


Contacts
Contact: Hayley Brooks 01612764902 hayley.brooks@cmft.nhs.uk

Locations
United Kingdom
Central Manchester University Hospitals NHS Foundation Trust Recruiting
Manchester, Manchester (Manchester borough), United Kingdom, M13 9WL
Contact: Hayley Brooks    01612764902    hayley.brooks@cmft.nhs.uk   
Principal Investigator: Simon Lloyd         
Sponsors and Collaborators
Hayley Brooks
Investigators
Principal Investigator: Simon Lloyd Central Manchester University Hospitals NHS Foundation Trust
  More Information

Responsible Party: Hayley Brooks, Simon Lloyd, Central Manchester University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02246231     History of Changes
Other Study ID Numbers: R01623
First Submitted: September 18, 2014
First Posted: September 22, 2014
Last Update Posted: September 22, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Neurofibromatoses
Neurofibroma
Neurofibromatosis 2
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neuroma, Acoustic
Neurilemmoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroma
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Neoplasms
Cranial Nerve Diseases


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