NCT02080312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 12, 2016

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

March 3, 2014

Results QC Date

December 21, 2015

Last Update Submit

February 11, 2016

Conditions

Meniere's Disease

Keywords

Meniere's diseaseendolymphatic hydrops

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • Extension of Contrast From Perilymph to CSF

    24 hours post injection

Study Arms (1)

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.

Drug: Magnevist (gadopentetate dimeglumine)

Interventions

Magnevist (gadopentetate dimeglumine)DRUG
intratympanic injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego Health System

San Diego, California, 92103, United States

Location

Related Publications (1)

  • 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.

    PMID: 25814661RESULT

MeSH Terms

Conditions

Meniere DiseaseEndolymphatic Hydrops

Interventions

Gadolinium DTPA

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pentetic AcidPolyaminesAminesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsCoordination Complexes

Results Point of Contact

Title
Julie Bykowski
Organization
UCSD
jbykowski@ucsd.edu
619-543-6766

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Radiology

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 6, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 12, 2016

Results First Posted

February 12, 2016

Record last verified: 2016-02

Locations

US(1)