<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/NCT03042416</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00055342</org_study_id>
    <nct_id>NCT03042416</nct_id>
  </id_info>
  <brief_title>18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety</brief_title>
  <official_title>18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alberta Health services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</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>
      Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific&#xD;
      patient populations:&#xD;
&#xD;
        1. Pediatric patients with congenital hyperinsulinism&#xD;
&#xD;
        2. Pediatric patients with neuroblastoma&#xD;
&#xD;
        3. Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor&#xD;
&#xD;
        4. Adult patients with a clinical suspicion of Parkinson's disease&#xD;
&#xD;
        5. Pediatric or Adult patients with primary brain tumors&#xD;
&#xD;
      This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton&#xD;
      PET Centre.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2017</start_date>
  <completion_date type="Actual">June 2, 2021</completion_date>
  <primary_completion_date type="Actual">March 5, 2021</primary_completion_date>
  <phase>Phase 3</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>Immediate safety evaluation</measure>
    <time_frame>Within 1 hour of injection</time_frame>
    <description>Clinical screen for adverse reactions to 18F-DOPA injection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delayed safety evaluation</measure>
    <time_frame>10-14 days after injection</time_frame>
    <description>A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delayed safety evaluation - referring physician</measure>
    <time_frame>6 months after injection</time_frame>
    <description>Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected</measure>
    <time_frame>Within 3 days after injection</time_frame>
    <description>Scan interpreter will evaluate the distribution of tracer and comment if expected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived clinical benefit</measure>
    <time_frame>6 months after injection</time_frame>
    <description>Questionnaire for referring physician to assess perceived clinical benefit of scan</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Congenital Hyperinsulinism</condition>
  <condition>Neuroblastoma</condition>
  <condition>Neuroendocrine Tumors</condition>
  <condition>Parkinson Disease</condition>
  <condition>Brain Glioma</condition>
  <arm_group>
    <arm_group_label>18F-DOPA scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>18F-DOPA (4 MBq/kg, minimum 110 MBq, maximum 600 MBq) intravenous. Single-dose 20-80 minutes prior to PET/CT scan of brain or whole body (depending on specific imaging protocol for patient).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-DOPA</intervention_name>
    <description>18F-DOPA intravenous injection single dose</description>
    <arm_group_label>18F-DOPA scan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Pediatric patients (less than 17 years old) with congenital hyperinsulinism&#xD;
&#xD;
          -  2. Pediatric patients (less than 17 years old) with neuroblastoma&#xD;
&#xD;
          -  3. Pediatric patients (less than 17 years old) or Adult patients (17 or older) with&#xD;
             known or clinically suspected neuroendocrine tumor outside of the pancreas&#xD;
&#xD;
          -  4. Adult patients (17 or older) with a clinical suspicion of Parkinson's disease.&#xD;
&#xD;
          -  5. Pediatric (less than 17 years old) or Adult patients (17 or older) with primary&#xD;
             brain tumors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to obtain consent&#xD;
&#xD;
          -  Weight &gt; 250 kg (weight limitation of PET/CT scanner)&#xD;
&#xD;
          -  Adult patients unable to lie flat for 20-30 minutes to complete the PET/CT scan&#xD;
&#xD;
          -  Young pediatric patients (less than 10 years old) who are unable to lie flat for 20-30&#xD;
             minutes and for whom clinical sedation is contraindicated (as determined by a&#xD;
             pediatric anaesthesiologist)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Lack of intravenous access&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan T Abele, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>January 6, 2022</last_update_submitted>
  <last_update_submitted_qc>January 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>18F-DOPA PET/CT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroblastoma</mesh_term>
    <mesh_term>Neuroendocrine Tumors</mesh_term>
    <mesh_term>Congenital Hyperinsulinism</mesh_term>
    <mesh_term>Nesidioblastosis</mesh_term>
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Hyperinsulinism</mesh_term>
  </condition_browse>
  <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/NCT03042416
org study id: Pro00055342
nct id: NCT03042416
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific
      patient populations:

        1. Pediatric patients with congenital hyperinsulinism

        2. Pediatric patients with neuroblastoma

        3. Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor

        4. Adult patients with a clinical suspicion of Parkinson's disease

        5. Pediatric or Adult patients with primary brain tumors

      This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton
      PET Centre.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Immediate safety evaluation
time frame: Within 1 hour of injection
description: Clinical screen for adverse reactions to 18F-DOPA injection
measure: Delayed safety evaluation
time frame: 10-14 days after injection
description: A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection
measure: Delayed safety evaluation - referring physician
time frame: 6 months after injection
description: Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection
measure: Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected
time frame: Within 3 days after injection
description: Scan interpreter will evaluate the distribution of tracer and comment if expected
measure: Perceived clinical benefit
time frame: 6 months after injection
description: Questionnaire for referring physician to assess perceived clinical benefit of scan
arm group label: 18F-DOPA scan
arm group type: Experimental
description: 18F-DOPA (4 MBq/kg, minimum 110 MBq, maximum 600 MBq) intravenous. Single-dose 20-80 minutes prior to PET/CT scan of brain or whole body (depending on specific imaging protocol for patient).
intervention type: Drug
intervention name: 18F-DOPA
description: 18F-DOPA intravenous injection single dose
arm group label: 18F-DOPA scan
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jonathan T Abele, MD
role: Principal Investigator
affiliation: University of Alberta
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Neuroblastoma
mesh term: Neuroendocrine Tumors
mesh term: Congenital Hyperinsulinism
mesh term: Nesidioblastosis
mesh term: Parkinson Disease
mesh term: Hyperinsulinism
sharing ipd: No