Search for inner ear window permeability using 17O-MRI

JRCT ID: jRCTs041210085

Registered date:18/10/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy adult, Meniere's disease
• Date of first enrollment: 16/11/2021
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Intratympanic administration of PSO17

Outcome(s)

• Primary Outcome: Evaluate if O17 migration to the perilymph and endolymphatic hydrops can be depicted
• Secondary Outcome: safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

STEP 1:
(1) Healthy adults 20 years and older
(2) Persons who have received sufficient explanation of the contents of this research and have obtained their written consent.
(3) Those who are 20 years of age or older when obtaining consent.
STEP2:
(1) Definite and probable cases of Meniere's disease as defined in the diagnostic criteria for Meniere's disease 2017 of the Japanese Society for Equilibrium research.
(2) Patients who have received sufficient explanation of the contents of this study and have given their written consent.
(3) The subject must be 20 years of age or older when obtaining consent.

Exclude criteria

Persons who fall under any of the following shall be excluded.

(1) Patients with implanted or implanted medical devices, etc., containing metal (except for medical devices that have been conditionally approved for compatibility with MRI systems), patients with tattoos on the upper body, or patients who cannot undergo MRI examinations due to claustrophobia, etc.
(2) Patients with severe scoliosis
(3) Patients suffering from other mental disorders
(4) Patients who are pregnant or suspected to be pregnant, those who plan or refuse to deny pregnancy, including their partners during the study period, and lactating patients
(5) Patients who are deemed unsuitable for participation in the study by the principal investigator or sub-investigator and have difficulty with MRI study.

Related Information

• Primary Sponsor: Sone Michihiko