7 Tesla MRI Evaluation of the Spine (Asymptomatic)
7 Tesla MRI Evaluation of the Spine
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
standard values (diameter in mm) of nerve roots/ganglia/neuroforamen in each segment
Time Frame: 1 year
|
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
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.
Time Frame: 1 year
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- R450
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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