Meniere's Disease
Conditions
Keywords
Meniere's disease, endolymphatic hydrops
Brief 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. 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.
Interventions
Sponsors
American Society of Head and Neck Radiology
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vestibular Endolymphatic Hydrops (EH) | 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) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extension of Contrast From Perilymph to CSF | 24 hours post injection | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intratympanic Injection 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.
Magnevist (gadopentetate dimeglumine) | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Intratympanic Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
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)
Time frame: 24 hours post injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intratympanic Injection | Cochlear Endolymphatic Hydrops (EH) | Absent enhancement | 0 participants |
| Intratympanic Injection | Cochlear Endolymphatic Hydrops (EH) | No Cochlear EH | 0 participants |
| Intratympanic Injection | Cochlear Endolymphatic Hydrops (EH) | Cochlear EH | 6 participants |
Primary
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.
Time frame: 24 hours post injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intratympanic Injection | Vestibular Endolymphatic Hydrops (EH) | Vestibular EH < 34% | 0 participants |
| Intratympanic Injection | Vestibular Endolymphatic Hydrops (EH) | Vestibular EH 34-50% | 4 participants |
| Intratympanic Injection | Vestibular Endolymphatic Hydrops (EH) | Vestibular EH >50% | 2 participants |
Secondary
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.
Time frame: 24 hours post injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intratympanic Injection | Extension of Contrast From Perilymph to CSF | Conspicuous enhancement in IAC | 1 participants |
| Intratympanic Injection | Extension of Contrast From Perilymph to CSF | Subtle enhancement in IAC | 2 participants |
| Intratympanic Injection | Extension of Contrast From Perilymph to CSF | No enhancement in IAC | 3 participants |