Meniere's DiseaseNCT02080312
Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
A study testing Magnevist (gadopentetate dimeglumine) in people with Meniere's Disease, run by University of California, San Diego at 1 site in United States.
Trial summary
This is a pilot study of patients with clinical symptoms of Ménière's disease using injection of diluted magnetic resonance imaging (MRI) contrast agent into the ear to evaluate inner ear structures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniere's Disease
- What is being tested?
- Magnevist (gadopentetate dimeglumine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Symptoms and clinical exam consistent with Ménière's disease
- Ability to undergo MR exam
- Interest in participating in this study
- Ability to provide informed consent
Who cannot join
- Children (under age 18),
- Contraindication to MR imaging (see attached UCSD MR Screening Form)
- Claustrophobia precluding MR exam without sedation
- Contraindication to receiving intravenous gadolinium-based contrast agent (see attached UCSD Contrast Policy)
- Patients who are pregnant or breast feeding (intravenous contrast agents are Category C)
- Contraindication to osmotic challenge (congestive heart failure, renal failure, hepatic failure)
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego Health System
San Diego, California, 92103
About this study
This is a pilot study of patients with clinical symptoms of Ménière's disease using injection of diluted magnetic resonance imaging (MRI) contrast agent into the ear to evaluate inner ear structures.
The goal is to reproduce imaging findings described by non-United States (US) institutions, improve on image quality with decreased scan time and evaluate the dynamics of the contrast movement into the inner ear structures.
Read the detailed description
Participants will be scheduled for study sessions on 2 consecutive days to include consent, baseline audiometric evaluation, intra-tympanic contrast administration, serial MR imaging, and follow-up audiometry evaluation in the injected ear.
Participants over 59 years old or who have medical conditions will have a blood test to check kidney function to ensure they can safely receive the contrast.
- Conditions
- Meniere's Disease
- Being tested
- Magnevist (gadopentetate dimeglumine)
- Keywords
- Meniere's disease, endolymphatic hydrops
- Medical subject headings
- Meniere Disease, Endolymphatic Hydrops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnevist (gadopentetate dimeglumine)Drug
| Study group | Role | What they receive |
|---|---|---|
| intratympanic injection | Experimental | Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure. Receives: Drug: Magnevist (gadopentetate dimeglumine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular "Endolymphatic Hydrops (EH)"
The relative volume of the non-enhancing endolymphatic space was visually assessed relative to the enhancing perilymphatic space on delayed post-IT contrast FLAIR MRI sequences and characterized as <34%, 34-50% or >50% of endolymphatic/perilymphatic volume.
Measured: 24 hours post injection
Cochlear "Endolymphatic Hydrops (EH)"
The relative volume of the scala media of the basal turn of the cochlea (non-enhancing endolymph) was visually assessed relative to the scala tympani and scala vestibuli (enhancing perilymph) on delayed post-IT contrast FLAIR MRI sequences. Cases were characterized as: No Cochlear EH (no perceptible distention of the scala media), Cochlear EH (perceptible distention of the scala media), or Absent enhancement (no contrast in the cochlear perilymph)
Measured: 24 hours post injection
Secondary outcomes (1)
Extension of Contrast From Perilymph to CSF
The fundus of the internal auditory canal (IAC) was visually inspected to determine if there was conspicuous, subtle, or no enhancement extending in the setting of prior IT contrast injection, indicating permeability of the cochlear modiolus.
Measured: 24 hours post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meniere's DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Head and Neck Radiology
- Responsible party
- Principal investigator, Julie Bykowski, MD, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080312
- Sponsor's protocol ID
- 120004
- Other IDs
- 115,342
- Status last verified
- Feb 2016
- First submitted
- 3 Mar 2014
- Last updated
- 12 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bykowski J, Harris JP, Miller M, Du J, Mafee MF. Intratympanic Contrast in the Evaluation of Meniere Disease: Understanding the Limits. AJNR Am J Neuroradiol. 2015 Jul;36(7):1326-32. doi: 10.3174/ajnr.A4277. Epub 2015 Mar 26.
PubMed 25814661
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
- ClinicalTrials.gov ID
- NCT02080312
- Acronym / sponsor ID
- 120004
- Conditions
- Meniere's Disease
- Keywords
- Meniere's disease, endolymphatic hydrops
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- American Society of Head and Neck Radiology
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Posted 12 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study of patients with clinical symptoms of Ménière's disease using injection of diluted magnetic resonance imaging (MRI) contrast agent into the ear to evaluate inner ear structures.
The goal is to reproduce imaging findings described by non-United States (US) institutions, improve on image quality with decreased scan time and evaluate the dynamics of the contrast movement into the inner ear structures.
Detailed description
Participants will be scheduled for study sessions on 2 consecutive days to include consent, baseline audiometric evaluation, intra-tympanic contrast administration, serial MR imaging, and follow-up audiometry evaluation in the injected ear.
Participants over 59 years old or who have medical conditions will have a blood test to check kidney function to ensure they can safely receive the contrast.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intratympanic injection | Experimental | Drug: Magnevist (gadopentetate dimeglumine)Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptoms and clinical exam consistent with Ménière's disease
- Ability to undergo MR exam
- Interest in participating in this study
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Children (under age 18),
- Contraindication to MR imaging (see attached UCSD MR Screening Form)
- Claustrophobia precluding MR exam without sedation
- Contraindication to receiving intravenous gadolinium-based contrast agent (see attached UCSD Contrast Policy)
- Patients who are pregnant or breast feeding (intravenous contrast agents are Category C)
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 |
|---|---|---|
| Magnevist (gadopentetate dimeglumine) | Drug | intratympanic injection |
Primary outcome
Vestibular "Endolymphatic Hydrops (EH)"
Time frame: 24 hours post injection
The relative volume of the non-enhancing endolymphatic space was visually assessed relative to the enhancing perilymphatic space on delayed post-IT contrast FLAIR MRI sequences and characterized as <34%, 34-50% or >50% of endolymphatic/perilymphatic volume.
Cochlear "Endolymphatic Hydrops (EH)"
Time frame: 24 hours post injection
The relative volume of the scala media of the basal turn of the cochlea (non-enhancing endolymph) was visually assessed relative to the scala tympani and scala vestibuli (enhancing perilymph) on delayed post-IT contrast FLAIR MRI sequences. Cases were characterized as: No Cochlear EH (no perceptible distention of the scala media), Cochlear EH (perceptible distention of the scala media), or Absent enhancement (no contrast in the cochlear perilymph)
1 secondary outcome
Extension of Contrast From Perilymph to CSF
Time frame: 24 hours post injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25814661Bykowski J, Harris JP, Miller M, Du J, Mafee MF. Intratympanic Contrast in the Evaluation of Meniere Disease: Understanding the Limits. AJNR Am J Neuroradiol. 2015 Jul;36(7):1326-32. doi: 10.3174/ajnr.A4277. Epub 2015 Mar 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnevist (gadopentetate dimeglumine) in people with Meniere's Disease, run by University of California, San Diego at 1 site in United States.
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 4 inclusion and 6 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 12 Feb 2016. 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 States. 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?
Yes. Results are posted in the registry (first posted 12 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Vestibular "Endolymphatic Hydrops (EH)" (time frame: 24 hours post injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02080312, which also lists 1 linked publication.
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 12 Feb 2016.