<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/NCT02245282</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00010345</org_study_id>
    <secondary_id>1R44CA180425</secondary_id>
    <nct_id>NCT02245282</nct_id>
  </id_info>
  <brief_title>Contrast Enhanced MRI of the Prostate</brief_title>
  <official_title>Contrast Enhanced MRI of the Prostate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OHSU Knight Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>OHSU Knight Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prostate cancer detection and disease progression monitoring relies on systematic multi-core&#xD;
      biopsies. Minimal invasive imaging capacities for lesion targeting and monitoring are badly&#xD;
      needed. The purpose of this study is to determine if a new MRI technique can identify and&#xD;
      monitor prostate disease progression. If so biopsy core number can be reduced to as small as&#xD;
      one, and frequency for biopsy repeat can be reduced. The new technique is about a new way of&#xD;
      analyzing the pictures taken as part of prostate MRI exam. This part is called dynamic&#xD;
      contrast-enhanced MRI. It involves an injection of contrast reagent (or dye) through the arm&#xD;
      vein during a time period when prostate MRI pictures are continuously taken.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to perform contrast-enhanced (CE) magnetic resonance imaging (MRI) at&#xD;
      OHSU on subjects with diagnosed prostate cancer. This pilot project will study 20 subjects&#xD;
      prior to their next scheduled clinical procedures (biopsy or radical prostatectomy). Data&#xD;
      from this project will be used to explore new capabilities of the software platform developed&#xD;
      under current SBIR funding. CE-MRI will involve the use of an extracellular (Gadolinium&#xD;
      based, Gd) contrast agent. When Gd is used, (dynamic-contrast-enhanced) DCE-MRI signal&#xD;
      intensity time-course data will be analyzed analytically using the so called &quot;shutter-speed&quot;&#xD;
      paradigm which takes into account of the effects of finite water exchange kinetics. Region of&#xD;
      interest (ROI) and high resolution (~millimeter) parametric maps of pathophysiologic&#xD;
      quantities, such as tumor vessel permeability, tumor perfusion, extracellular extravascular&#xD;
      volume fraction, will be generated from the DCE-MRI data. All parameters will be compared to&#xD;
      literature results for software validation and correlated with pathology for clinical&#xD;
      potential.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Actual">December 12, 2018</completion_date>
  <primary_completion_date type="Actual">December 12, 2018</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>Prostate Cancer Detection and Aggressiveness Monitoring by Contrast Enhanced MRI</measure>
    <time_frame>within 60 days after MRI data collection</time_frame>
  </primary_outcome>
  <enrollment type="Actual">14</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 20 subjects will be studied under this protocol. Subjects will be selected from&#xD;
        patients scheduled for prostate biopsies with known prostate lesions. Subjects will also be&#xD;
        recruited from prostate cancer patients who choose radical prostatectomy as disease&#xD;
        management plan. The research project will be introduced to a potential subject by a&#xD;
        urologist at OHSU. If interested, the subject will then be contacted through phone to&#xD;
        participate in the study by an investigator or a research assistant on the research team.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men, age &gt;18 years.&#xD;
&#xD;
          -  Any patient scheduled for prostate biopsy repeat or radical prostatectomy.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who would be normally excluded from undergoing an MRI examination - patients&#xD;
             with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of&#xD;
             a strong magnetic field.&#xD;
&#xD;
          -  Patients who are unable to cooperate for an MRI exam.&#xD;
&#xD;
          -  Major surgery within a month of enrollment.&#xD;
&#xD;
          -  Prostate biopsy six weeks prior to enrollment.&#xD;
&#xD;
          -  Subject-reported reaction to gadolinium contrast reagent.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Garzotto, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OHSU Knight Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advanced Imaging Research Center, OHSU</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 15, 2020</last_update_submitted>
  <last_update_submitted_qc>September 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>OHSU Knight Cancer Institute</investigator_affiliation>
    <investigator_full_name>Mark Garzotto, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be shared to Imbio LLC</ipd_description>
  </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/NCT02245282
org study id: IRB00010345
secondary id: 1R44CA180425
nct id: NCT02245282
lead sponsor: 
collaborator: 
has dmc: Yes
Prostate cancer detection and disease progression monitoring relies on systematic multi-core
      biopsies. Minimal invasive imaging capacities for lesion targeting and monitoring are badly
      needed. The purpose of this study is to determine if a new MRI technique can identify and
      monitor prostate disease progression. If so biopsy core number can be reduced to as small as
      one, and frequency for biopsy repeat can be reduced. The new technique is about a new way of
      analyzing the pictures taken as part of prostate MRI exam. This part is called dynamic
      contrast-enhanced MRI. It involves an injection of contrast reagent (or dye) through the arm
      vein during a time period when prostate MRI pictures are continuously taken.
The aim of the study is to perform contrast-enhanced (CE) magnetic resonance imaging (MRI) at
      OHSU on subjects with diagnosed prostate cancer. This pilot project will study 20 subjects
      prior to their next scheduled clinical procedures (biopsy or radical prostatectomy). Data
      from this project will be used to explore new capabilities of the software platform developed
      under current SBIR funding. CE-MRI will involve the use of an extracellular (Gadolinium
      based, Gd) contrast agent. When Gd is used, (dynamic-contrast-enhanced) DCE-MRI signal
      intensity time-course data will be analyzed analytically using the so called "shutter-speed"
      paradigm which takes into account of the effects of finite water exchange kinetics. Region of
      interest (ROI) and high resolution (~millimeter) parametric maps of pathophysiologic
      quantities, such as tumor vessel permeability, tumor perfusion, extracellular extravascular
      volume fraction, will be generated from the DCE-MRI data. All parameters will be compared to
      literature results for software validation and correlated with pathology for clinical
      potential.
observational model: Cohort
time perspective: Prospective
measure: Prostate Cancer Detection and Aggressiveness Monitoring by Contrast Enhanced MRI
time frame: within 60 days after MRI data collection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mark Garzotto, MD
role: Principal Investigator
affiliation: OHSU Knight Cancer Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: OHSU Knight Cancer Institute
investigator full name: Mark Garzotto, MD
investigator title: Professor
mesh term: Prostatic Neoplasms
sharing ipd: Yes
ipd description: Data will be shared to Imbio LLC