<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04445584</url>
  </required_header>
  <id_info>
    <org_study_id>R450</org_study_id>
    <nct_id>NCT04445584</nct_id>
  </id_info>
  <brief_title>High-resolution MRI (7 Tesla) of the Cervical Spine in Asymptomatic Individuals</brief_title>
  <official_title>High-resolution MRI (7 Tesla) of the Cervical Spine in Asymptomatic Individuals - Development of Reference Standards</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Balgrist University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Balgrist University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      High-resolution MRI (7 Tesla) of the cervical spine is capable to provide good&#xD;
      differentiation between nerve and surrounding tissues within foramen und allows to reliably&#xD;
      quantify the diameter of nerve roots/ganglia. Secondly, detailed anatomy of vertebral artery&#xD;
      and its relation to neural structures / foramina can be assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">February 1, 2022</completion_date>
  <primary_completion_date type="Actual">February 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>standard values (diameter in mm) of nerve roots/ganglia/neuroforamen in each segment</measure>
    <time_frame>1 year</time_frame>
    <description>measure the diameter of the neuroforamen (in mm) and the diameter of each cervical nerve root/ganglion within the neuroforamen (in mm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <enrollment type="Actual">80</enrollment>
  <condition>Magnetic Resonance Imaging</condition>
  <condition>Cervical Spine Anatomy</condition>
  <condition>Reference Standard</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>7 Tesla MRI</intervention_name>
    <description>7 Tesla MRI</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        asymptomatic individuals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent as documented by signature (Appendix Informed Consent Form)&#xD;
&#xD;
          -  &gt;18 years old&#xD;
&#xD;
          -  no cervical back pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous surgery&#xD;
&#xD;
          -  tumor patients&#xD;
&#xD;
          -  pregnancy or breast feeding&#xD;
&#xD;
          -  any MRI contra-indications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Balgrist University Hospital</name>
      <address>
        <city>Zurich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>August 30, 2022</last_update_submitted>
  <last_update_submitted_qc>August 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Balgrist University Hospital</investigator_affiliation>
    <investigator_full_name>Reto Sutter, MD</investigator_full_name>
    <investigator_title>Chief of radiology, MD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04445584
org study id: R450
nct id: NCT04445584
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
High-resolution MRI (7 Tesla) of the cervical spine is capable to provide good
      differentiation between nerve and surrounding tissues within foramen und allows to reliably
      quantify the diameter of nerve roots/ganglia. Secondly, detailed anatomy of vertebral artery
      and its relation to neural structures / foramina can be assessed.
observational model: Cohort
time perspective: Prospective
measure: standard values (diameter in mm) of nerve roots/ganglia/neuroforamen in each segment
time frame: 1 year
description: measure the diameter of the neuroforamen (in mm) and the diameter of each cervical nerve root/ganglion within the neuroforamen (in mm)
measure: 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
description: 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.
intervention type: Diagnostic Test
intervention name: 7 Tesla MRI
description: 7 Tesla MRI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Balgrist University Hospital
investigator full name: Reto Sutter, MD
investigator title: Chief of radiology, MD
sharing ipd: No