Listed exemplary ICH codes in an openly designed study, which covers a broader spectrum of skull base lesions: H.90.0 - H.90.8, H.91.0, H91.9, H93.8, H93.9, D33.1, D33.3, D33.7, D33.9, D32.9, D36.1, C.72.5
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: General: persons with a minimum age of 18 years who are able to give their informed consent Subproject 1 and 2, Step 1: Healthy Volunteers Subproject 1, Step 2: Patients for CI evaluation (screening MRI examination for the exclusion of abnormalities of the auditory nerves, inner ears and central auditory path) Subproject 2, Step 2: Patients with known or suspected untreated skull base lesions (e.g. vestibular Schwannomas, pseudotumors of the orbit, paragangliomas)
Exclusion criteria
Exclusion criteria: General: - General MRI contraindications for MRI, e.g. implants such as non-conditional MR-suitable pacemakers or auto-defibrillators, implanted neural stimulators and ocular metal foreign bodies (e.g. metal shards) - Conditions that could hinder the conduct of the study (e.B. morbid obesity, pronounced claustrophobia) - Existing unnecessary risks (pregnancy, surgery of an unsafe nature). Subproject 1 and 2, Step 1: Known serious disease of the central nervous system. Subproject 1, Step 2: Known serious disease of the central nervous system (other than possibly the one associated with hearing loss in the patient group). Subproject 2, Step 2: Known serious disease of the central nervous system (except skull base lesions in the patient group)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subproject 1) Overall image quality of CI (cochlear implant) pre-diagnosis for the detection of relevant anatomical details: Blind evaluations of MRI-experienced evaluators (doctors) when using the optimized T2 SPACE CS sequence compared to the CISS sequence. Subproject 2) Overall image quality in delineation of skull-base lesions: blind evaluations by differently experienced (neuro-)radiologists (numerical 100-point scale). | — |
Secondary
| Measure | Time frame |
|---|---|
| Scan time reduction, imaging parameters after optimization, various parameters for image quality. | — |
Countries
Germany
Contacts
Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg, Universitätsmedizin Oldenburg