NCT04445584

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jun 2020Sep 2027

Study Start

First participant enrolled

June 1, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Expected
Last Updated

October 2, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

June 19, 2020

Last Update Submit

October 1, 2025

Conditions

Magnetic Resonance ImagingCervical Spine AnatomyReference Standard

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

    1 year

Interventions

7 Tesla MRIDIAGNOSTIC_TEST

7 Tesla MRI

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

asymptomatic individuals

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of radiology, MD

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 24, 2020

Study Start

June 1, 2020

Primary Completion

February 1, 2022

Study Completion (Estimated)

September 30, 2027

Last Updated

October 2, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)