Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent

Meniere's Disease Clinical Trial

Official title:

Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080312
• Other study ID #: 120004
• Secondary ID: 115,342
• Status: Completed
• Phase: N/A
• First received: March 3, 2014
• Last updated: February 11, 2016
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2016
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

Intervention

Drug:
• Magnevist (gadopentetate dimeglumine)

Locations

Country	Name	City	State
United States	UC San Diego Health System	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	American Society of Head and Neck Radiology

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bykowski J, Harris JP, Miller M, Du J, Mafee MF. Intratympanic Contrast in the Evaluation of Menière Disease: Understanding the Limits. AJNR Am J Neuroradiol. 2015 Jul;36(7):1326-32. doi: 10.3174/ajnr.A4277. Epub 2015 Mar 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	24 hours post injection	No
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)	24 hours post injection	No
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.	24 hours post injection	No