<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/NCT04495959</url>
  </required_header>
  <id_info>
    <org_study_id>H20-02418</org_study_id>
    <nct_id>NCT04495959</nct_id>
  </id_info>
  <brief_title>Dynamic Whole Body PET/ MRI</brief_title>
  <official_title>Dynamic Whole Body Positron Emission Tomography/ Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>British Columbia Cancer Agency</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>British Columbia Cancer Agency</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>
      Prostate cancer is the third most common cause of cancer death in men. Most patients with&#xD;
      localized prostate cancer will be cured with surgery or radiation therapy, but up to 35% of&#xD;
      patients will have their prostate cancer return.Current conventional imaging modalities have&#xD;
      limitations particularly at low prostate specific antigen levels. This study proposes to use&#xD;
      68Ga-HTK03149 Dynamic Whole Body (DWB) Positron Emission Tomography / Magnetic Resonance&#xD;
      Imaging (PET/MRI) scans which targets prostate-specific membrane antigens (PSMA) to detect&#xD;
      where in the body the prostate cancer has recurred.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective registry study to evaluate the diagnostic utility of 68Ga-HTK03149 DWB&#xD;
      PET/MRI to stage patients with high risk prostate cancer who will subsequently under go&#xD;
      radical prostatectomy.&#xD;
&#xD;
      Eligible subjects will undergo a 68Ga-HTK03149 DWB PET/MRI at the University of British&#xD;
      Columbia (UBC) - Vancouver, Djavad Mowafaghian Centre for Brain Health where the UBC PET/MRI&#xD;
      is located. Each subject will receive a 18F-DCFPyL PET/MRI DWB scan at the UBC centre, as&#xD;
      part of this research study. Each study subject will receive a bolus intravenous dose of&#xD;
      18F-DCFPyL. The subject will be placed on the PET/MRI scanner for a dynamic whole body PET&#xD;
      scan. Then after a brief break off the scanner, they will return to the scanner for the&#xD;
      standard whole body PET/MRI scan.&#xD;
&#xD;
      The PET/MRI scan will take approximately 3.5 hours of patient time above and beyond the time&#xD;
      needed for standard of care.&#xD;
&#xD;
      Medical History Questionnaire: Demographic and medical history data will be collected either&#xD;
      in person before the PET scan appointment or by mail or phone, whichever is the most&#xD;
      convenient to the subject.&#xD;
&#xD;
      Follow-up assessments: All subjects will be contacted by phone the day after the injection of&#xD;
      68Ga-HTK03149. The subjects will be asked if they experienced any undesirable effects during&#xD;
      the 12 hours after the administration of 68Ga-HTK03149. The local site attending nuclear&#xD;
      medicine physician will then make an assessment as to whether these effects are likely&#xD;
      related to 68Ga-HTK03149 administration.&#xD;
&#xD;
      All subjects will be followed for 5 years following the 68Ga-HTK03149 PET/CT exam to assess&#xD;
      the presence of recurrence. The evaluation will include a chart review of available imaging,&#xD;
      laboratory tests, and treatment. The data required can be obtained from a review of the&#xD;
      patient's paper and electronic charts, supplemented by telephone contact as needed to&#xD;
      complete the information.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">August 2024</start_date>
  <completion_date type="Anticipated">September 2028</completion_date>
  <primary_completion_date type="Anticipated">September 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 of Dynamic Whole Body 68Ga-HTK03149PET/MRI imaging in the assessment of high risk prostate cancer.</measure>
    <time_frame>5 years after 68Ga-HTK03149DWB PET/MRI scan</time_frame>
    <description>Determination of sensitivity when compared with pathology reports</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy of combined DWB PET/MRI to assess the extent of prostate cancer</measure>
    <time_frame>5 years after 68Ga-HTK03149 DWB PET/MRI scan</time_frame>
    <description>Comparison of parametric images derived from dynamic whole body PET imaging to conventional static PET images as well as MRI images . Assessment as to whether parametric images are able to distinguish normal organ accumulation (e.g. ureters, kidneys, bladder, bowel) from tumour uptake, based on the kinetics of radiotracer accumulation. Quantitative comparison of image contrast and signal-to-noise ratio (SNR) between static and parametric images from dynamic scans will be completed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with self-reported 68Ga-HTK03149 related adverse event</measure>
    <time_frame>12 hours post 68Ga-HTK03149 injection</time_frame>
    <description>Patients will be contacted by phone the day after the 68Ga-HTK03149PET/CT scan to see if they experienced any adverse events in the 12 hours following the 18F-DCFPyL injection. These are recorded and evaluated for severity and likelihood they are related to the study drug. All adverse events will be recorded and summarized in the final report.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Prostatic Cancer</condition>
  <arm_group>
    <arm_group_label>68Ga-HTK03149 PET/MRI DWB scan</arm_group_label>
    <description>All participants will undergo the same procedures listed in &quot;Detailed Description&quot; in the protocol section.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>68Ga-HTK03149</intervention_name>
    <description>PET/MRI scan with radiotracer 68Ga-HTK03149</description>
    <arm_group_label>68Ga-HTK03149 PET/MRI DWB scan</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with newly diagnosed high risk prostate cancer (UCSF/CAPRA score of 6 or higher)&#xD;
        who are scheduled to undergo radical prostatectomy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with biopsy-proven high risk prostate cancer (UCSF/CAPRA score 6 or higher)&#xD;
             scheduled for radical prostatectomy.&#xD;
&#xD;
          -  Able to not use the washroom for the duration of the dynamic imaging scanning.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status of 2 or less.&#xD;
&#xD;
          -  Able to lie supine for the required duration of the scans&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Meet the exclusion criteria for the appropriate standard of care imaging.&#xD;
&#xD;
          -  Experience claustrophobia.&#xD;
&#xD;
          -  Subjects with severe renal disease or acutely deteriorating renal function (eGRF&lt;30&#xD;
             mL/min)&#xD;
&#xD;
          -  Subjects may not take part in this study if they have a pacemaker, an implanted&#xD;
             defibrillator, or certain other implanted electronic or metallic devices, shrapnel, or&#xD;
             other metal.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Heather Saprunoff</last_name>
    <phone>604-877-6000</phone>
    <phone_ext>2818</phone_ext>
    <email>hsaprunoff@bccancer.bc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>BC Cancer</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 27, 2023</last_update_submitted>
  <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>No</sharing_ipd>
    <ipd_description>no plan</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/NCT04495959
org study id: H20-02418
nct id: NCT04495959
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prostate cancer is the third most common cause of cancer death in men. Most patients with
      localized prostate cancer will be cured with surgery or radiation therapy, but up to 35% of
      patients will have their prostate cancer return.Current conventional imaging modalities have
      limitations particularly at low prostate specific antigen levels. This study proposes to use
      68Ga-HTK03149 Dynamic Whole Body (DWB) Positron Emission Tomography / Magnetic Resonance
      Imaging (PET/MRI) scans which targets prostate-specific membrane antigens (PSMA) to detect
      where in the body the prostate cancer has recurred.
This is a prospective registry study to evaluate the diagnostic utility of 68Ga-HTK03149 DWB
      PET/MRI to stage patients with high risk prostate cancer who will subsequently under go
      radical prostatectomy.

      Eligible subjects will undergo a 68Ga-HTK03149 DWB PET/MRI at the University of British
      Columbia (UBC) - Vancouver, Djavad Mowafaghian Centre for Brain Health where the UBC PET/MRI
      is located. Each subject will receive a 18F-DCFPyL PET/MRI DWB scan at the UBC centre, as
      part of this research study. Each study subject will receive a bolus intravenous dose of
      18F-DCFPyL. The subject will be placed on the PET/MRI scanner for a dynamic whole body PET
      scan. Then after a brief break off the scanner, they will return to the scanner for the
      standard whole body PET/MRI scan.

      The PET/MRI scan will take approximately 3.5 hours of patient time above and beyond the time
      needed for standard of care.

      Medical History Questionnaire: Demographic and medical history data will be collected either
      in person before the PET scan appointment or by mail or phone, whichever is the most
      convenient to the subject.

      Follow-up assessments: All subjects will be contacted by phone the day after the injection of
      68Ga-HTK03149. The subjects will be asked if they experienced any undesirable effects during
      the 12 hours after the administration of 68Ga-HTK03149. The local site attending nuclear
      medicine physician will then make an assessment as to whether these effects are likely
      related to 68Ga-HTK03149 administration.

      All subjects will be followed for 5 years following the 68Ga-HTK03149 PET/CT exam to assess
      the presence of recurrence. The evaluation will include a chart review of available imaging,
      laboratory tests, and treatment. The data required can be obtained from a review of the
      patient's paper and electronic charts, supplemented by telephone contact as needed to
      complete the information.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity of Dynamic Whole Body 68Ga-HTK03149PET/MRI imaging in the assessment of high risk prostate cancer.
time frame: 5 years after 68Ga-HTK03149DWB PET/MRI scan
description: Determination of sensitivity when compared with pathology reports
measure: Accuracy of combined DWB PET/MRI to assess the extent of prostate cancer
time frame: 5 years after 68Ga-HTK03149 DWB PET/MRI scan
description: Comparison of parametric images derived from dynamic whole body PET imaging to conventional static PET images as well as MRI images . Assessment as to whether parametric images are able to distinguish normal organ accumulation (e.g. ureters, kidneys, bladder, bowel) from tumour uptake, based on the kinetics of radiotracer accumulation. Quantitative comparison of image contrast and signal-to-noise ratio (SNR) between static and parametric images from dynamic scans will be completed.
measure: Number of participants with self-reported 68Ga-HTK03149 related adverse event
time frame: 12 hours post 68Ga-HTK03149 injection
description: Patients will be contacted by phone the day after the 68Ga-HTK03149PET/CT scan to see if they experienced any adverse events in the 12 hours following the 18F-DCFPyL injection. These are recorded and evaluated for severity and likelihood they are related to the study drug. All adverse events will be recorded and summarized in the final report.
arm group label: 68Ga-HTK03149 PET/MRI DWB scan
description: All participants will undergo the same procedures listed in "Detailed Description" in the protocol section.
intervention type: Drug
intervention name: 68Ga-HTK03149
description: PET/MRI scan with radiotracer 68Ga-HTK03149
arm group label: 68Ga-HTK03149 PET/MRI DWB scan
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 99 Years
healthy volunteers: No
last name: Heather Saprunoff
phone: 604-877-6000
phone ext: 2818
email: hsaprunoff@bccancer.bc.ca
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No
ipd description: no plan