NCT04441554

Brief Summary

High-resolution MRI (7 Tesla) of the 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

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
14mo left

Started Mar 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 Progress85%
Mar 2020Sep 2027

Study Start

First participant enrolled

March 4, 2020

Completed
4 months until next milestone

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
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

7.6 years

First QC Date

June 19, 2020

Last Update Submit

July 14, 2026

Conditions

Cervical Spine DiseaseMagnetic Resonance Imaging

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 the spine

Eligibility Criteria

Age18 Years+
Sexall
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 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

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
SPONSOR INVESTIGATOR
PI Title
chief of radiology

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 22, 2020

Study Start

March 4, 2020

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)