Effect of Implant Position on Magnetic Resonance Image Distortion

NCT02246231 | Completed DMC

• 1 other identifier: R01623
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurofibromatosis Type 2

Outcome Measures

Primary Outcomes (1)

• To study the effect of magnet orientation in auditory brainstem implants/ cochlear implants in determining the size of signal void seen on MRI scanning.

  1 year

Secondary Outcomes (1)

• To identify if there is an angle at which the signal void is minimised

  1 year

Study Arms (1)

NF2 who has an auditory implant

EXPERIMENTAL

Device: MR imaging

Interventions

MR imaging DEVICE

NF2 who has an auditory implant

Eligibility Criteria

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

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Central Manchester University Hospitals NHS Foundation Trust

Manchester, Manchester (Manchester Borough), M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Neurofibromatosis 2

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neuroma, Acoustic; Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neuroma; Neoplastic Syndromes, Hereditary; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Simon Lloyd

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 22, 2014
• Study Start: February 3, 2014
• Primary Completion: January 31, 2015
• Study Completion: January 31, 2015
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

GB (1)