<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/NCT04441983</url>
  </required_header>
  <id_info>
    <org_study_id>R449</org_study_id>
    <nct_id>NCT04441983</nct_id>
  </id_info>
  <brief_title>Foot/Ankle at 7T MRI</brief_title>
  <official_title>High-Resolution MRI (7 Tesla) Findings of the Plantar Plate Compared With Current Clinical Standard Sequences (1.5 or 3 Tesla) and Surgical Reference Standard</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>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  To evaluate standard clinical sequences for 7 Tesla MRI of the foot and/or ankle to&#xD;
           improve detailed depiction of the complex anatomy of this region.&#xD;
&#xD;
        -  To evaluate various pathologies of the foot and/or ankle (plantar plate tears, Morton&#xD;
           neuroma, tendon tears, ligament tears etc.).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2022</start_date>
  <completion_date type="Anticipated">October 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2025</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>sensitivity / specificity</measure>
    <time_frame>2 years</time_frame>
    <description>The sensitivity/specificity for detection of various pathologies in the foot/ankle, for exampleMorton neuroma, plantar plate tears and tendon injuries at 7T MRI</description>
  </primary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Plantar Plate Tear</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>7 Tesla MRI of the foot</intervention_name>
    <description>7 Tesla MRI</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have undergone a forefoot MRI for clinical indications (or previous study)&#xD;
        will be enrolled&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent as documented by signature (Appendix Informed Consent Form)&#xD;
&#xD;
          -  at least 18 years old&#xD;
&#xD;
          -  Study group: Patients with specific pathologies (i.e. Morton neuroma, tendon tears,&#xD;
             plantar plate tears) as proven by 1,5 or 3T MRI or asymptomatic subjects (to look at&#xD;
             the normal microanatomy of different structures, mainly the plantar plate)&#xD;
&#xD;
          -  Control group: No evidence of the respective pathology.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous foot surgery with metal in vivo&#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>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reto Sutter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Balgrist University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christoph Germann, MD</last_name>
    <phone>+41443863322</phone>
    <email>christoph.germann@balgrist.ch</email>
  </overall_contact>
  <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>head of radiology, medical doctor, principal investigator</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/NCT04441983
org study id: R449
nct id: NCT04441983
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
-  To evaluate standard clinical sequences for 7 Tesla MRI of the foot and/or ankle to
           improve detailed depiction of the complex anatomy of this region.

        -  To evaluate various pathologies of the foot and/or ankle (plantar plate tears, Morton
           neuroma, tendon tears, ligament tears etc.).
observational model: Cohort
time perspective: Prospective
measure: sensitivity / specificity
time frame: 2 years
description: The sensitivity/specificity for detection of various pathologies in the foot/ankle, for exampleMorton neuroma, plantar plate tears and tendon injuries at 7T MRI
intervention type: Diagnostic Test
intervention name: 7 Tesla MRI of the foot
description: 7 Tesla MRI
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Reto Sutter, MD
role: Principal Investigator
affiliation: Balgrist University Hospital
last name: Christoph Germann, MD
phone: +41443863322
email: christoph.germann@balgrist.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Balgrist University Hospital
investigator full name: Reto Sutter, MD
investigator title: head of radiology, medical doctor, principal investigator
sharing ipd: No