<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/NCT04441554</url>
  </required_header>
  <id_info>
    <org_study_id>R448</org_study_id>
    <nct_id>NCT04441554</nct_id>
  </id_info>
  <brief_title>High-resolution 7 Tesla MRI of C-spine - Comparison With 3 Tesla MRI</brief_title>
  <official_title>High-resolution MRI (7 Tesla) of Foraminal Stenosis and Differentiation of the Degenerated Discovertebral Unit - Comparison With 3 Tesla MRI</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 differentiate osseous spurs&#xD;
      from discus-material and better depict the compressed nerve in the neuroforamen compared to&#xD;
      3T MRI.&#xD;
&#xD;
      Provide the surgeon with a detailed high-resolution anatomical image before surgery and&#xD;
      potential no need for CT (if the bony anatomy is of crucial importance).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 31, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2023</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>differentiation of compressed nerves in neuroforamen (7T vs 3T)</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Magnetic Resonance Imaging</condition>
  <condition>Cervical Spine Disease</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>7 Tesla MRI</intervention_name>
    <description>7 Tesla MRI of cervical spine</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have undergone a MRI of the spine for clinical indications will be enrolled&#xD;
        through consecutive ongoing recruitment in daily clinical practice at Balgrist University&#xD;
        Hospital Zurich.&#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;
          -  Patients with cervical back pain (radiculopathy) and scheduled surgery for foraminal&#xD;
             stenosis or central stenosis or cervical periradicular injection therapy (PRT)&#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>
    <status>Recruiting</status>
    <contact>
      <last_name>Christoph Germann, MD</last_name>
      <phone>+41443863322</phone>
      <email>christoph.germann@balgrist.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</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</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Diseases</mesh_term>
  </condition_browse>
  <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/NCT04441554
org study id: R448
nct id: NCT04441554
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
High-resolution MRI (7 Tesla) of the cervical 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).
observational model: Cohort
time perspective: Prospective
measure: differentiation of compressed nerves in neuroforamen (7T vs 3T)
time frame: 2 years
intervention type: Diagnostic Test
intervention name: 7 Tesla MRI
description: 7 Tesla MRI of cervical spine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Balgrist University Hospital
investigator full name: Reto Sutter, MD
investigator title: chief of radiology
mesh term: Spinal Diseases
sharing ipd: No