NCT04441554

Brief 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).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 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

First Submitted

Initial submission to the registry

June 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

July 31, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

September 5, 2024

Status Verified

August 1, 2024

Enrollment Period

5.4 years

First QC Date

June 19, 2020

Last Update Submit

September 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

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

    2 years

Interventions

7 Tesla MRIDIAGNOSTIC_TEST

7 Tesla MRI of cervical spine

Eligibility Criteria

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

Patients who have undergone a MRI of the spine for clinical indications will be enrolled through consecutive ongoing recruitment in daily clinical practice at Balgrist University Hospital Zurich.

You may qualify if:

  • 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)

You may not qualify if:

  • previous surgery
  • tumor patients
  • pregnancy or breast feeding
  • 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

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 22, 2020

Study Start

July 31, 2020

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

September 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations