- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04441554
7 Tesla MRI Evaluation of the Spine
July 14, 2026 updated by: Reto Sutter, MD
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-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.
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
differentiation of compressed nerves in neuroforamen (7T vs 3T)
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2020
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Study Registration Dates
First Submitted
June 19, 2020
First Submitted That Met QC Criteria
June 19, 2020
First Posted (Actual)
June 22, 2020
Study Record Updates
Last Update Posted (Actual)
July 15, 2026
Last Update Submitted That Met QC Criteria
July 14, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R448
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.