Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278129
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-19
Brief Title:
Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménières Disease
Sponsor:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study Overview
Official Title:
Evaluation of the Diagnostic and Prognostic Efficacy of Magnetic Resonance Imaging in Patients With Acute Sensorineural Hearing Loss and Ménières Disease
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MRI_SSHLMD
Brief Summary:
Evaluation of the diagnostic and prognostic efficacy of nuclear magnetic resonance imaging in patients with acute sensorineural hearing loss or in patients suffering from probable or definite MD The neuroradiological and audiological evaluation are held on in the same day in order to better clarify the radiological and clinical correlates
Detailed Description:
Aims of the study
1 Evaluate the diagnostic accuracy of MRI with the collection of more specific sequences for the inner ear 3D-FLAIR in identifying intralabyrinthine anomalies in patients with Ménières disease or acutesubacute sudden hearing loss and not only the retrochlear pathologyneurological causes
2 Characterize the vascular and inflammatory MRI patterns
3 Define the prognostic role of MRI with pre- and post-contrast 3D-FLAIR sequence eliminating confounding factors such as MRI execution time the methodology used the effect of previous therapy and the criteria for defining improvement
4 Correlate 4-hour 3D-FLAIR MRI imaging data with clinical and hematological data
1 Evaluate the diagnostic accuracy of MRI with the collection of more specific sequences for the inner ear 3D-FLAIR in identifying intralabyrinthine anomalies in patients with Ménières disease or acutesubacute sudden hearing loss and not only the retrochlear pathologyneurological causes
2 Characterize the vascular and inflammatory MRI patterns
3 Define the prognostic role of MRI with pre- and post-contrast 3D-FLAIR sequence eliminating confounding factors such as MRI execution time the methodology used the effect of previous therapy and the criteria for defining improvement
4 Correlate 4-hour 3D-FLAIR MRI imaging data with clinical and hematological data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None