Trial Outcomes & Findings for Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent (NCT NCT02080312)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

24 hours post injection

Results posted on

2016-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intratympanic Injection n=6 Participants 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)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intratympanic Injection n=6 Participants 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)
Vestibular "Endolymphatic Hydrops (EH)" Vestibular EH < 34%	0 participants
Vestibular "Endolymphatic Hydrops (EH)" Vestibular EH 34-50%	4 participants
Vestibular "Endolymphatic Hydrops (EH)" Vestibular EH >50%	2 participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Intratympanic Injection n=6 Participants 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)
Cochlear "Endolymphatic Hydrops (EH)" No Cochlear EH	0 participants
Cochlear "Endolymphatic Hydrops (EH)" Cochlear EH	6 participants
Cochlear "Endolymphatic Hydrops (EH)" Absent enhancement	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intratympanic Injection n=6 Participants 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)
Extension of Contrast From Perilymph to CSF Conspicuous enhancement in IAC	1 participants
Extension of Contrast From Perilymph to CSF Subtle enhancement in IAC	2 participants
Extension of Contrast From Perilymph to CSF No enhancement in IAC	3 participants

Adverse Events

Intratympanic Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie Bykowski

UCSD

Phone: 619-543-6766

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place