xml: <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/NCT05992298</url>
    </required_header>
    <id_info>
      <org_study_id>I0171</org_study_id>
      <nct_id>NCT05992298</nct_id>
    </id_info>
    <brief_title>Feasibility Testing of 7-Tesla Magnetic Resonance Imaging</brief_title>
    <official_title>Explorative Technical Feasibility Testing of 7-Tesla Magnetic Resonance Imaging of the Musculoskeletal System and of the Head</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Reto Sutter, MD</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>
        The goal of the current project is to explore and develop the technical feasibility of&#xD;
        non-invasive imaging of the human musculoskeletal system and head with the first 7T MR&#xD;
        scanner with a CE mark to identify areas where the higher field promises significant benefits&#xD;
        in qualitative image quality. For a subset of the planned exams, state-of-the art 7T or 3T&#xD;
        images will be used as standard of reference to comparatively gauge the qualitative image&#xD;
        quality of the investigational 7T images.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 7, 2023</start_date>
    <completion_date type="Anticipated">February 29, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 29, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Qualitative image quality of 7 T MRI</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Current-day feasibility of various types of MR examinations of the human musculoskeletal system. The primary outcomes of small consistent series of the study are visual gradings and qualitative measures of image quality. Image quality is rated by independent readers using Likert scales.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">780</enrollment>
    <condition>Magnetic Resonance Imaging</condition>
    <arm_group>
      <arm_group_label>7 T MRI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>7 T MRI vs 3 T MRI</intervention_name>
      <description>Adult healthy and patient volunteers will undergo a ca. 1 hour examination of non-invasive magnetic-resonance imaging at 7T, and, if appropriate, a closely matching examination at 3T as a standard of reference.</description>
      <arm_group_label>7 T MRI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Consent to undergo a 7T (and, if appropriate a comparative 3T) MRI exam.&#xD;
  &#xD;
            -  For some of the consistent small series: presence of a specific condition of the&#xD;
               musculoskeletal system or of the head. This can include traumatic or degenerative&#xD;
               changes, e.g., of tendons, cartilage, muscle, peripheral nerves, ligaments, and bones,&#xD;
               or in the brain, as well as focal lesions, e.g., tumors.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Contraindications to undergo a MRI examination at a field strength of 7 Tesla or at 3&#xD;
               Tesla.&#xD;
  &#xD;
            -  Irregular anatomy and/or tissue properties&#xD;
  &#xD;
            -  Inability to consent - for any reason.&#xD;
  &#xD;
            -  Body mass above 200 kg.&#xD;
  &#xD;
            -  Body mass below 30 kg.&#xD;
  &#xD;
            -  Women: pregnancy.&#xD;
  &#xD;
            -  Age below 18.&#xD;
  &#xD;
            -  Known or suspected non-compliance, drug or alcohol abuse.&#xD;
  &#xD;
            -  Inability to follow the procedures of the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Reto Sutter, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Balgrist University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Reto Sutter, Prof.</last_name>
      <phone>+41 44 386 33 08</phone>
      <email>reto.sutter@balgrist.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Daniel Nanz, Prof.</last_name>
      <phone>+41 44 510 70 04</phone>
      <email>daniel.nanz@balgristcampus.ch</email>
    </overall_contact_backup>
    <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>Reto Sutter, Prof.</last_name>
        <phone>+41 44 386 33 08</phone>
        <email>reto.sutter@balgrist.ch</email>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Balgrist University Hospital</investigator_affiliation>
      <investigator_full_name>Reto Sutter, MD</investigator_full_name>
      <investigator_title>Prof. Dr. med. Reto Sutter</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992298
  org study id: I0171
  nct id: NCT05992298
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of the current project is to explore and develop the technical feasibility of
        non-invasive imaging of the human musculoskeletal system and head with the first 7T MR
        scanner with a CE mark to identify areas where the higher field promises significant benefits
        in qualitative image quality. For a subset of the planned exams, state-of-the art 7T or 3T
        images will be used as standard of reference to comparatively gauge the qualitative image
        quality of the investigational 7T images.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Qualitative image quality of 7 T MRI
  time frame: through study completion, an average of 1 year
  description: Current-day feasibility of various types of MR examinations of the human musculoskeletal system. The primary outcomes of small consistent series of the study are visual gradings and qualitative measures of image quality. Image quality is rated by independent readers using Likert scales.
  arm group label: 7 T MRI
  arm group type: Experimental
  intervention type: Other
  intervention name: 7 T MRI vs 3 T MRI
  description: Adult healthy and patient volunteers will undergo a ca. 1 hour examination of non-invasive magnetic-resonance imaging at 7T, and, if appropriate, a closely matching examination at 3T as a standard of reference.
  arm group label: 7 T MRI
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Reto Sutter, Prof.
  role: Principal Investigator
  affiliation: Balgrist University Hospital
  last name: Reto Sutter, Prof.
  phone: +41 44 386 33 08
  email: reto.sutter@balgrist.ch
  last name: Daniel Nanz, Prof.
  phone: +41 44 510 70 04
  email: daniel.nanz@balgristcampus.ch
  facility: 
  status: Recruiting
  contact: 
  country: Switzerland
  responsible party type: Sponsor-Investigator
  investigator affiliation: Balgrist University Hospital
  investigator full name: Reto Sutter, MD
  investigator title: Prof. Dr. med. Reto Sutter