7 Tesla MRI Evaluation of the Spine (Asymptomatic)

7 Tesla MRI Evaluation of the Spine

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.

Study Overview

• Status: Recruiting
• Conditions: Magnetic Resonance Imaging; Cervical Spine Anatomy; Reference Standard
• Intervention / Treatment: Diagnostic test: 7 Tesla MRI

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8008
      • Recruiting
      • Balgrist University Hospital
      • Contact: Christoph Germann, MD; Phone Number: +41443863322; Email: christoph.germann@balgrist.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

asymptomatic individuals

Description

Inclusion criteria:

• Informed consent as documented by signature (Appendix Informed Consent Form)
• >18 years old
• Patients presenting chronic back pain (> 2 months) without recent trauma, previous MRI (1,5 or 3T) for clinicals indications or asymptomatic individuals (for depicting normal microanatomy)

Exclusion criteria:

• previous surgery
• tumor patients
• pregnancy or breast feeding
• any MRI contra-indications
• any MRI contra-indications

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): February 1, 2022
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: R450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No