<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/NCT02190344</url>
  </required_header>
  <id_info>
    <org_study_id>019-2014</org_study_id>
    <nct_id>NCT02190344</nct_id>
  </id_info>
  <brief_title>Functionality of an 8-Channel Paddle Coil for Use With MRI</brief_title>
  <official_title>Study to Evaluate the Functionality of an Eight-Channel Paddle Coil System Using MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ontario Institute for Cancer Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine the functionality of an eight-channel paddle coil&#xD;
      system which is to be used in future MRI studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate cancer is the most common malignancy among men and the second leading cause of&#xD;
      cancer death in men. Currently, MRI is the best imaging modality for both detecting prostate&#xD;
      cancer and determining the presence of extra-prostatic extension. Multiparametric Magnetic&#xD;
      Resonance, combining T2-weighted, diffusion-weighted and dynamic contrast enhanced imaging&#xD;
      (DCE-MRI) is recommended as the minimum acceptable standard for prostate MRI examination.&#xD;
      However, MPMRI still lacks diagnostic accuracy in the transition zone, where distinguishing&#xD;
      cancer from proliferative nodules has proven difficult. DCE-MRI techniques evaluate the time&#xD;
      course of signal intensities after administration of a contrast medium and have been used to&#xD;
      successfully differentiate benign from malignant tumours, particularly in breast and prostate&#xD;
      cancer. Unfortunately, current DCE approaches have high false-positive rates and are limited&#xD;
      in distinguishing prostatitis and vascularized BPH nodules from cancer in active surveillance&#xD;
      studies. Future studies that employ spectroscopic MR imaging of the prostate after&#xD;
      administration of Hyperpolarized (13C) Pyruvate Injection, are expected to provide a robust,&#xD;
      non-invasive method to assist in detecting and characterizing prostate cancer. The objective&#xD;
      of this study is to determine the functionality of an eight-channel paddle coil system which&#xD;
      is to be used in future Hyperpolarized (13C) Pyruvate Injection studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ability of Coil to produce MRI images</measure>
    <time_frame>1 hour</time_frame>
    <description>functional with adequate SNR&#xD;
functional with non-adequate SNR&#xD;
non-functional</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Prostate in Healthy Males</condition>
  <arm_group>
    <arm_group_label>Functionality of 8-channel paddle coil system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>8-channel paddle coil</intervention_name>
    <description>MRI Coil</description>
    <arm_group_label>Functionality of 8-channel paddle coil system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male volunteers between 18 and 80 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contra-indication for MR imaging (such as pacemakers, surgical implants, foreign&#xD;
             metal objects in the body)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Cunningham, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>June 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>April 8, 2019</last_update_submitted>
  <last_update_submitted_qc>April 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Eight</keyword>
  <keyword>Channel</keyword>
  <keyword>Paddle</keyword>
  <keyword>Coil</keyword>
  <keyword>MRI</keyword>
  <keyword>Prostate</keyword>
  <keyword>Healthy Male</keyword>
  <!-- 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/NCT02190344
org study id: 019-2014
nct id: NCT02190344
lead sponsor: 
collaborator: 
has dmc: No
The objective of this study is to determine the functionality of an eight-channel paddle coil
      system which is to be used in future MRI studies.
Prostate cancer is the most common malignancy among men and the second leading cause of
      cancer death in men. Currently, MRI is the best imaging modality for both detecting prostate
      cancer and determining the presence of extra-prostatic extension. Multiparametric Magnetic
      Resonance, combining T2-weighted, diffusion-weighted and dynamic contrast enhanced imaging
      (DCE-MRI) is recommended as the minimum acceptable standard for prostate MRI examination.
      However, MPMRI still lacks diagnostic accuracy in the transition zone, where distinguishing
      cancer from proliferative nodules has proven difficult. DCE-MRI techniques evaluate the time
      course of signal intensities after administration of a contrast medium and have been used to
      successfully differentiate benign from malignant tumours, particularly in breast and prostate
      cancer. Unfortunately, current DCE approaches have high false-positive rates and are limited
      in distinguishing prostatitis and vascularized BPH nodules from cancer in active surveillance
      studies. Future studies that employ spectroscopic MR imaging of the prostate after
      administration of Hyperpolarized (13C) Pyruvate Injection, are expected to provide a robust,
      non-invasive method to assist in detecting and characterizing prostate cancer. The objective
      of this study is to determine the functionality of an eight-channel paddle coil system which
      is to be used in future Hyperpolarized (13C) Pyruvate Injection studies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Ability of Coil to produce MRI images
time frame: 1 hour
description: functional with adequate SNR
functional with non-adequate SNR
non-functional
arm group label: Functionality of 8-channel paddle coil system
arm group type: Experimental
intervention type: Device
intervention name: 8-channel paddle coil
description: MRI Coil
arm group label: Functionality of 8-channel paddle coil system
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Charles Cunningham, PhD
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
facility: 
country: Canada
responsible party type: Sponsor