Clinical trial NCT06278129: Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière's Disease
Official title: Evaluation of the Diagnostic and Prognostic Efficacy of Magnetic Resonance Imaging in Patients With Acute Sensorineural Hearing Loss and Ménière's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sudden Sensorineural Hearing Loss
Meniere Disease
Ménière's Vertigo
Meniere's Disease Aggravated
Inner Ear Disease
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from acute sudden hearing loss and Meniere's disease according to the criteria of the American Academy of Otolaryngology.

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 Ménière's disease or acute/subacute sudden hearing loss and not only the retrochlear pathology/neurological 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

Eligibility criteria: Inclusion Criteria:

age \> 18 years

* onset of symptoms less than 10 days
* no previous episodes of sudden ipsilateral hearing loss
* no systemic or oral corticosteroid intake in the previous month
* Informed consent

Exclusion Criteria:

* Current or previous otopathy and/or labyrinth diseases of known cause
* Known nervous system disorders
* Patients with renal insufficiency (creatinine level \> 1.5 mg/dL)
* Patients with pacemakers, other metal implants, claustrophobics and known psychiatric disorders
* Pregnant patients Materials and methods Diagnostic evaluation at enrollment (T0)
* Audiological or ENT examination
* Liminal tonal audiometric exam, vocal, impedance measurement, otoacoustic emissions, video-impulse test, oVEMPS, cVEMPS, stabilometry
* Hematological tests: complete blood count, ESR, PCR, creatininemia, CMV IgM, EBV IgM, ANA, glycemia, study of predisposing genetic factors

Primary outcomes:
measure: Evaluation of inner ear structures in MRI images
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Audiology and Neuroradiology - Milan (Italy)
Study officials:
References:
citation: Conte G, Di Berardino F, Sina C, Zanetti D, Scola E, Gavagna C, Gaini L, Palumbo G, Capaccio P, Triulzi F. MR Imaging in Sudden Sensorineural Hearing Loss. Time to Talk. AJNR Am J Neuroradiol. 2017 Aug;38(8):1475-1479. doi: 10.3174/ajnr.A5230. Epub 2017 May 25.
citation: Conte G, Caschera L, Calloni S, Barozzi S, Di Berardino F, Zanetti D, Scuffi C, Scola E, Sina C, Triulzi F. MR Imaging in Meniere Disease: Is the Contact between the Vestibular Endolymphatic Space and the Oval Window a Reliable Biomarker? AJNR Am J Neuroradiol. 2018 Nov;39(11):2114-2119. doi: 10.3174/ajnr.A5841. Epub 2018 Oct 18.
citation: Conte G, Di Berardino F, Zanetti D, Avignone S, Sina C, Iofrida E, Triulzi F. The 'full-blown' MRI of sudden hearing loss: 3D FLAIR in a patient with bilateral metastases in the internal auditory canals. Neuroradiol J. 2018 Feb;31(1):39-41. doi: 10.1177/1971400917736927. Epub 2017 Oct 19.
citation: Berardino FD, Conte G, Turati F, Ferraroni M, Zanetti D. Cochlear implantation in Meniere's disease: a systematic review of literature and pooled analysis. Int J Audiol. 2020 Jun;59(6):406-415. doi: 10.1080/14992027.2020.1720922. Epub 2020 Feb 6.
citation: Conte G, Lo Russo F, Caschera L, Zanetti D, Castorina P, Sina C, Triulzi F, Di Berardino F. Audiovestibular Phenotypes and Advanced Magnetic Resonance Imaging Features of Cochlin Gene Mutation Carriers. Audiol Neurootol. 2019;24(4):166-173. doi: 10.1159/000501292. Epub 2019 Aug 7.
citation: Conte G, Di Berardino F, Zanetti D, Iofrida EF, Scola E, Sbaraini S, Filipponi E, Cinnante C, Gaini LM, Ambrosetti U, Triulzi F, Pignataro L, Capaccio P. Early Magnetic Resonance Imaging for Patients With Idiopathic Sudden Sensorineural Hearing Loss in an Emergency Setting. Otol Neurotol. 2019 Oct;40(9):1139-1147. doi: 10.1097/MAO.0000000000002389.
citation: Conte G, Di Berardino F, Mastrapasqua RF, Casale S, Scola E, Capaccio P, Triulzi F, Pignataro L, Zanetti D. Prognostic Value of Early Magnetic Resonance Imaging Patterns in Sudden Hearing Loss. Audiol Neurootol. 2022;27(1):64-74. doi: 10.1159/000515153. Epub 2021 Apr 23.