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NCT04441554 Clinical Trial

High-resolution 7 Tesla MRI of C-spine - Comparison With 3 Tesla MRI

Magnetic Resonance Imaging Clinical Trial

Official title:
High-resolution MRI (7 Tesla) of Foraminal Stenosis and Differentiation of the Degenerated Discovertebral Unit - Comparison With 3 Tesla MRI

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04441554
Other study ID # R448
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 31, 2020
Est. completion date December 1, 2023

Study information
Verified date February 2023
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 differentiate osseous spurs from discus-material and better depict the compressed nerve in the neuroforamen compared to 3T MRI. Provide the surgeon with a detailed high-resolution anatomical image before surgery and potential no need for CT (if the bony anatomy is of crucial importance).

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 1, 2023
Est. primary completion date November 30, 2023
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 - Patients with cervical back pain (radiculopathy) and scheduled surgery for foraminal stenosis or central stenosis or cervical periradicular injection therapy (PRT) 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 of cervical spine

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 differentiation of compressed nerves in neuroforamen (7T vs 3T) 2 years
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