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NCT04445584 Clinical Trial

High-resolution MRI (7 Tesla) of the Cervical Spine in Asymptomatic Individuals

Magnetic Resonance Imaging Clinical Trial

Official title:
High-resolution MRI (7 Tesla) of the Cervical Spine in Asymptomatic Individuals - Development of Reference Standards

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04445584
Other study ID # R450
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date February 1, 2022

Study information
Verified date August 2022
Source Balgrist University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

High-resolution MRI (7 Tesla) of the cervical spine is capable to provide good differentiation between nerve and surrounding tissues within foramen und allows to reliably quantify the diameter of nerve roots/ganglia. Secondly, detailed anatomy of vertebral artery and its relation to neural structures / foramina can be assessed.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date February 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Informed consent as documented by signature (Appendix Informed Consent Form) - >18 years old - no cervical back pain Exclusion Criteria: - previous surgery - tumor patients - pregnancy or breast feeding - any MRI contra-indications

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 7 Tesla MRI
7 Tesla MRI

Locations
Country Name City State
Switzerland Balgrist University Hospital Zurich

Sponsors (1)
Lead Sponsor Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary standard values (diameter in mm) of nerve roots/ganglia/neuroforamen in each segment measure the diameter of the neuroforamen (in mm) and the diameter of each cervical nerve root/ganglion within the neuroforamen (in mm) 1 year
Secondary relation of vertebral artery to neural structures - assessment of contact between ganglion/spinal nerve and vertebral artery by assessing the presence of fat tissue between these structures. to assess if there is contact between the vertebral artery and the ganglion/spinal nerve at each segment and each side if no fat tissue is interposed between the ganglion and vertebral artery it is classified as having contact. If contact is present, the length of contact (in mm) will be measured in the axial plane. 1 year
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