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Not yet recruitingNCT06712303Updated Dec 2, 2024

Role of Multi-detector CT and MRI in Diagnosis of Congenital Inner Ear Anomalies

An observational study in Ear Disease, Inner, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-12-02.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
26
Sex
All
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Study summary

Evaluation of combined value of Multi-detector computed tomography (MDCT) and Magnetic resonance imaging (MRI) in the diagnosis of congenital abnormalities of the inner ear and internal auditory canal in patients with congenital hearing loss and preoperative evaluation of cochlear implant candidates.

Read the detailed description

Introduction:

Inner ear malformation (IEM) with associated sensoryneural hearing loss (SNHL) is a major cause of childhood disability.

The embryology of the inner ear must be known as many of the inner ear malformations present as a result of the arrest during the various stages of embryology.

Congenital malformations of the inner ear may be considered in two broad categories:

  1. malformations with pathologic changes that involve only the membranous labyrinth.
  2. malformations that involve both the osseous and the membranous labyrinth.

Congenital sensorineural hearing loss arises as a result of abnormalities in the inner ear, the vestibulocochlear nerve, or the processing centres of the brain. The abnormality may have a genetic cause or be a sequel of infection or injury at birth; in some cases, no cause is identified.

One of the paths in the investigation of congenital sensorineural hearing loss (CSNHL) is to try to characterize its aetiology through the inner ear evaluation using high resolution computer tomography (CT) scans. With minor malformation, it is not always possible for a simple visual inspection to recognize if the structure in the inner ear is normal or not.

Both CT and MR can be used to look at inner ear malformations but often both techniques are complementary. CT is preferred when associated middle or external ear malformations must be excluded. Magnetic resonance is preferred when subtle changes in the membranous labyrinth or abnormalities of the nerves in the internal auditory canal must be visualised Moreover, some changes inside the membranous labyrinth can only be seen on sub-millimetric heavily T2-weighted MR images.

Only MR can demonstrate the abnormal course, hypoplasia or aplasia of the vestibulocochlear nerve (or one of is three branches) and facial nerve.

HRCT and MRI temporal bone are complementary to each other in evaluating children for cochlear implantation as HRCT is excellent for demonstrating bony details but, lack in providing details of inner ear neural structures and MRI is better than CT in demonstrating vestibulocochlear nerves.

Combined HRCT and MRI studies are mandatory for evaluation of inner ear, the radiologist must be familiar with imaging findings that absolutely contraindicate implantation (Cochlear aplasia, cochlear nerve aplasia and labyrinthine aplasia), and with those that relatively contraindicate implantation (labyrinthitis ossificans, other inner ear dysplasia) and with other findings that could significantly alter or complicate surgery (hypo plastic mastoid process, facial nerve dehiscence, oto-mastoiditis)

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Conditions studied

  • Ear Disease, Inner

Keywords

  • MRI
  • Ct
  • Ear disease
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In context

Labyrinth Diseases

21 studies on the registry are indexed under Labyrinth Diseases; 8 are open to participants now.

Browse Labyrinth Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any age group come for cochlear implantation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all patient of inner ear anomalies

Exclusion criteria

Exclusion Criteria:

  • studied groups ,mri
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
26 participants (estimated)
Patient registry
No

Interventions

  • DeviceMRI ,ct

    Every patient will be subjected to 1. MSCT examination: All patients will undergo MSCT (Siemens somatom 32 slice ,16 slice ,GE bright speed 16 slice ) Non contrast high-resolution CT of the temporal bone with the following parameters:{ 0.75-mm collimation, 130 kvp, 20 mA, topogram length 265}. Patients will be scanned in the supine position with craniocaudal direction. Scanning will be parallel to the orbito-meatal line from the lower margin of the external auditory meatus and extended upward to the arcuate eminence of the superior semicircular canal, as seen on the lateral topogram. Followed by image reconstruction in both the axial and coronal planes to evaluate the inner ear and its malformations, The initial data sets will be reconstructed at 0.6 mm slice thickness. The raw axial image data set can be reconstructed with a section thickness of as little as 0.3 mm to obtain high-quality coronal reformatted images. A 512 × 512 matrix is used, and all the images are reviewed wit

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What researchers measure

Primary outcomes

  1. Inner ear anomalies detection by CT and MRI

    accurate and early diagnosis of patsuffer from suffer from sensory neural hearing loss (SNHL)

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2024; primary completion for Dec 2026, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2024
First posted
Dec 2, 2024
StartEst.
Dec 20, 2024
Primary completionEst.
Dec 20, 2026
CompletionEst.
Dec 20, 2027
Last update
Dec 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06712303
Lead sponsor
Assiut University
Responsible party
Sarah Khaled Fahmi (Principal Investigator, Assiut University) — Principal investigator
First posted
Dec 2, 2024
Start date
Dec 20, 2024 (estimated)
Primary completion
Dec 20, 2026 (estimated)
Completion
Dec 20, 2027 (estimated)
Last update
Dec 2, 2024

Study contacts

Sarah K Fahmi
Contact
Khaledsarah155@gmail.com
+201554577818 ext. +01017507865
Yasser Y. Mohamed
study director · Assistant professor doctor
Hossam E. Mohamed
study director · Professor doctor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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