Neurofibromatosis Type 2NCT02246231
Effect of Implant Position on Magnetic Resonance Image Distortion
A study testing MR imaging in people with Neurofibromatosis Type 2, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurofibromatosis Type 2
- What is being tested?
- MR imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Feb 2014to 31 Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Central Manchester University Hospitals NHS Foundation Trust
Manchester, Manchester (Manchester Borough), M13 9WL
About this study
Official title: The Effect of Changes in Head Position on Magnetic Resonance Image Distortion in Patients With Auditory Implants
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.
Read the 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.
- Conditions
- Neurofibromatosis Type 2
- Being tested
- MR imaging
- Medical subject headings
- Neurofibromatosis 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR imagingDevice
| Study group | Role | What they receive |
|---|---|---|
| NF2 who has an auditory implant | Experimental | Not described Receives: Device: MR imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the effect of magnet orientation in auditory brainstem implants/ cochlear implants in determining the size of signal void seen on MRI scanning.
Measured: 1 year
Secondary outcomes (1)
To identify if there is an angle at which the signal void is minimised
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study start3 Feb 2014
- Primary completion31 Jan 2015
- Study completion31 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurofibromatosis Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Simon Lloyd, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246231
- Sponsor's protocol ID
- R01623
- Status last verified
- Mar 2020
- First submitted
- 18 Sep 2014
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Changes in Head Position on Magnetic Resonance Image Distortion in Patients With Auditory Implants
- ClinicalTrials.gov ID
- NCT02246231
- Acronym / sponsor ID
- R01623
- Conditions
- Neurofibromatosis Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 3 Feb 2014 (actual)
- Primary completion
- 31 Jan 2015 (actual)
- Study completion
- 31 Jan 2015 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NF2 who has an auditory implant | Experimental | Device: MR imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR imaging | Device | NF2 who has an auditory implant |
Primary outcome
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
1 secondary outcome
To identify if there is an angle at which the signal void is minimised
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
Related trials for Neurofibromatosis Type 2
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 2
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
Intracranial Meningioma, Recurrent Meningioma
Active, not recruitingPhase 2
Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia
Juvenile Myelomonocytic Leukemia, Neurofibromatosis Type 1
RecruitingPhase 1
PAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform Neurofibromas
NF1 Mutation, Neurofibroma Plexiform
Not yet recruitingPhase 2
Selumetinib for NF2-Related Schwannomatosis
Neurofibromatosis Type 2, NF2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Lloyd principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR imaging in people with Neurofibromatosis Type 2, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.