Search for inner ear window permeability using 17O-MRI

Phase 1

• Conditions: Healthy adult, Meniere's disease; Meniere's disease, endolymphatic hydrops; D008575, D018159

• Registration Number: JPRN-jRCTs041210085
• Lead Sponsor: Sone Michihiko

Brief Summary

17O-labeled water was found to reach the inner ear quickly when administered intratympanically. In the setting of this study, it was difficult to distinguish between the endolymph and perilymph on imaging. This is a new insight into the dynamics of water in the inner ear.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-18
• Results First Posted: 2022-11-03
• Study Completion: 2023-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 6

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified