- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513467
3T Magnetic Resonance Neurography (3T MRN)
High-resolution MR Neurography Evaluation of the Cervical Spine at 3 Tesla
The goal of this observational study is to evaluate whether optimized high-resolution MRI can better visualize very fine nerves in the cervical spine and neck region compared to standard MRI. The main question it aims to answer is:
Can high-resolution MRI reliably show small nerves and potentially detect their injuries or diseases that are often invisible on conventional MRI scans?
Participants will come once to Balgrist University Hospital for a one-hour visit. They will fill out a questionnaire and have a single 30-minute MRI scan of the cervical spine without contrast.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diseases and injuries of the nerves in the area of the cervical spine and neck region are among the most common causes of pain in the neck, shoulder, and arm areas. To clarify the cause of the pain, an MRI examination of the neck region is therefore very often requested in order to visualize the nerves. However, some very fine nerves - in particular the smaller branches of the cervical nerves - are so thin that they can usually only be visualized incompletely or not at all reliably with conventional MRI techniques. As a result, injuries or diseases of some nerves frequently remain undetected, even though these nerves perform important motor functions - for example, the movement of the shoulder, the arm, or (in rare cases) also the diaphragm. Through modified and technically advanced MRI protocols (in particular high-resolution MR neurography), significantly better images can now be generated.
This study therefore investigates whether these special techniques can also clearly depict even very small nerves, so that these techniques can be applied in the future to patients with pathological changes and these changes can be better identified.
Participation involves a single visit to Balgrist University Hospital. The time commitment is one hour. Participants receive oral information about the project, complete a short questionnaire, and subsequently undergo the MRI examination. The time spent in the MRI scanner is approximately 30 minutes.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Frederik Abel, MD
- Phone Number: +41 44 386 33 27
- Email: frederik.abel@balgrist.ch
Study Contact Backup
- Name: Reto Sutter, MD
- Phone Number: +41 44 386 33 08
- Email: reto.sutter@balgrist.ch
Study Locations
-
-
-
Zurich, Switzerland, 8008
- Balgrist University Hospital
-
Contact:
- Frederik Abel, MD
- Phone Number: +41 44 386 33 27
- Email: frederik.abel@balgrist.ch
-
Contact:
- Reto Sutter, MD
- Phone Number: +41 44 386 33 08
- Email: reto.sutter@balgrist.ch
-
Principal Investigator:
- Reto Sutter, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- written consent to agree to participate in this study
Exclusion Criteria:
- <18 years of age
- pregnancy
- known cervical spine pathology or history of neck surgery
- contraindication to perform non-contrast-enhanced MRI
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy volunteers
|
Clinical standard three-dimensional magnetic resonance neurography sequences with high spatial resolution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of visible small-caliber nerve segments
Time Frame: Within 12 weeks after MRI acquisition during radiological readout
|
Visibility of small-caliber cervical nerves (phrenic, spinal accessory, dorsal scapular, vagus nerve) per segment (proximal, midsegment, distal) on both sides (left/right) per volunteer.
Two board-certified radiologists with experience in MR Neurography will independently determine visibility (binary score: 0 = not visible, 1 = visible).
Visibility is defined as continuous depiction of the nerve segment over its entire length with signal intensity clearly distinguishable from background tissue.
|
Within 12 weeks after MRI acquisition during radiological readout
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Image quality score across different acceleration factors
Time Frame: Within 12 weeks after MRI acquisition during radiological readout
|
Image quality of small-caliber cervical nerves across varying acceleration factors will be independently assessed by two radiologists using a 4-point Likert scale (0 = poor/non-diagnostic, 2 = moderate, 3 = good, 4 = excellent).
|
Within 12 weeks after MRI acquisition during radiological readout
|
|
Inter-reader agreement for visibility and image quality
Time Frame: Within 12 weeks after MRI acquisition during radiological readout
|
Reliability of visibility and image quality of small-caliber cervical nerves and nerve segments will be assessed by inter-reader agreement.
|
Within 12 weeks after MRI acquisition during radiological readout
|
|
Frequency of anatomic variants
Time Frame: Within 12 weeks after MRI acquisition during radiological readout
|
Frequency of anatomical variants of small-caliber cervical nerves, reported as percentage of volunteers.
|
Within 12 weeks after MRI acquisition during radiological readout
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R509
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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