<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/NCT02980679</url>
  </required_header>
  <id_info>
    <org_study_id>DX-CTC-003</org_study_id>
    <secondary_id>HREBA.CC-16-0695</secondary_id>
    <nct_id>NCT02980679</nct_id>
  </id_info>
  <brief_title>A Study to Compare the Safety and Imaging Pattern of Cyclotron-produced Technetium (CTC) vs. Generator-produced Technetium (G-PERT) in People With Thyroid Disorders Who Need Surgery</brief_title>
  <official_title>A Pivotal Phase III Study of Cyclotron-produced Tc-99m Pertechnetate (CTC) Compared to Generator-produced Tc-99m Pertechnetate (G-PERT) in Subjects With Thyroid Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      A 99mTc Pertechnetate (G-PERT) scan is a nuclear medicine test that can create an image of&#xD;
      the thyroid gland and other organs. G-PERT is approved by Health Canada for the direct&#xD;
      imaging and measurement of thyroid uptake.&#xD;
&#xD;
      Doctors and researchers at the University of Alberta have developed a new method of producing&#xD;
      99mTc Pertechnetate (called CTC). It is made in a cyclotron at the Medical Isotope and&#xD;
      Cyclotron Facility (MICF) at the University of Alberta, Edmonton, Alberta. This new&#xD;
      production method will provide another source of 99mTc Pertechnetate. The aim of this study&#xD;
      is to confirm that CTC is safe and can be used interchangeably with G-PERT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical trial will be a Phase III, prospective, crossover, image interpretation blinded,&#xD;
      single site study. All subjects will receive Tc-99m pertechnetate (one CTC and one G-PERT&#xD;
      administration separated by at least 48 hours) and subsequently be imaged for thyroid uptake&#xD;
      and whole body biodistribution. The order of the scans will be randomized. The thyroid image&#xD;
      will be interpreted for uptake / no uptake in the thyroid, and the whole body biodistribution&#xD;
      image will be interpreted for uptake / no uptake in selected anatomical sites. Interpretation&#xD;
      of thyroid imaging results will be compared with other clinical findings (such as&#xD;
      pre-surgical ultrasound, fine needle aspirate, and post-surgical pathology results, when&#xD;
      available). All imaging assessments will be conducted by 1 blinded Nuclear Medicine&#xD;
      physician. A safety evaluation will be conducted on all subjects receiving CTC, consisting of&#xD;
      vital signs, haematology and SMA-12 serum biochemistry profile (pre-injection and&#xD;
      post-imaging), and, for both CTC and G-PERT, an adverse event assessment (until the subject&#xD;
      leaves the Nuclear Medicine department) after each administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2017</start_date>
  <completion_date type="Actual">February 25, 2019</completion_date>
  <primary_completion_date type="Actual">February 25, 2019</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>Clinical Comparability of CTC with G-PERT</measure>
    <time_frame>up to 1 year</time_frame>
    <description>The primary efficacy endpoint is the clinical comparability of CTC with G-PERT consisting of a combination of the following results:&#xD;
A thyroid image, assessed for uptake or no uptake in the thyroid.&#xD;
A whole body biodistribution study, assessed for uptake or no uptake in selected anatomical areas.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in vital signs after CTC injection</measure>
    <time_frame>Before CTC injection and after CTC scan (within ~30 min)</time_frame>
    <description>Vital signs are measured before injection of CTC and after CTC scan and changes will be summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in haematology / SMA-12 serum biochemistry after CTC injection</measure>
    <time_frame>Before CTC injection and after CTC scan (within ~30 min)</time_frame>
    <description>A blood sample is drawn before injection of CTC and after CTC scan. The haematology and SMA-12 serum biochemistry parameters will be recorded and all changes will be summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Subjects will be monitored for adverse events after CTC and G-PERT scans while in the Nuclear Medicine Department. All adverse events observed or reported will be recorded and assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of CTC with other clinical findings</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Correlation of thyroid images with other clinical findings (such as pre-surgical ultrasound, FNA, and post-surgical pathology results, when available).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CTC diagnostic outcomes and parameters</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Calculation of diagnostic outcomes (TP, TN, FP, FN) and the corresponding diagnostic parameters (sensitivity, specificity, accuracy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall clinical comparability of CTC with G-PERT</measure>
    <time_frame>up to 1 year</time_frame>
    <description>The overall clinical comparability of CTC with G-PERT using diagnostic outcomes (True Positive, True Negative, False Positive, False Negative) to determine the corresponding diagnostic parameters (sensitivity, specificity, accuracy).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Thyroid Gland Diseases</condition>
  <arm_group>
    <arm_group_label>CTC and G-PERT Imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One experimental (CTC) and one standard (G-PERT) scan, at least 48 hours apart, before thyroid surgery. The order of the scans will be randomized.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CTC</intervention_name>
    <description>After injection of CTC, a whole body and thyroid scan will be performed.</description>
    <arm_group_label>CTC and G-PERT Imaging</arm_group_label>
    <other_name>Cyclotron-produced technetium</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>G-PERT</intervention_name>
    <description>After injection of G-PERT, a whole body and thyroid scan will be performed.</description>
    <arm_group_label>CTC and G-PERT Imaging</arm_group_label>
    <other_name>Generator-produced technetium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female ≥ 18 years of age and &lt; 80 years of age.&#xD;
&#xD;
          2. Have a proven or suspected thyroid pathology that requires surgery by standard&#xD;
             clinical criteria.&#xD;
&#xD;
          3. Able and willing to follow instructions and comply with the protocol.&#xD;
&#xD;
          4. Provide written informed consent prior to participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Nursing or pregnant females.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd P McMullen, MD, PhD, FRCSC, FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>April 1, 2022</last_update_submitted>
  <last_update_submitted_qc>April 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2022</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>Thyroid Diseases</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/NCT02980679
org study id: DX-CTC-003
secondary id: HREBA.CC-16-0695
nct id: NCT02980679
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A 99mTc Pertechnetate (G-PERT) scan is a nuclear medicine test that can create an image of
      the thyroid gland and other organs. G-PERT is approved by Health Canada for the direct
      imaging and measurement of thyroid uptake.

      Doctors and researchers at the University of Alberta have developed a new method of producing
      99mTc Pertechnetate (called CTC). It is made in a cyclotron at the Medical Isotope and
      Cyclotron Facility (MICF) at the University of Alberta, Edmonton, Alberta. This new
      production method will provide another source of 99mTc Pertechnetate. The aim of this study
      is to confirm that CTC is safe and can be used interchangeably with G-PERT.
The clinical trial will be a Phase III, prospective, crossover, image interpretation blinded,
      single site study. All subjects will receive Tc-99m pertechnetate (one CTC and one G-PERT
      administration separated by at least 48 hours) and subsequently be imaged for thyroid uptake
      and whole body biodistribution. The order of the scans will be randomized. The thyroid image
      will be interpreted for uptake / no uptake in the thyroid, and the whole body biodistribution
      image will be interpreted for uptake / no uptake in selected anatomical sites. Interpretation
      of thyroid imaging results will be compared with other clinical findings (such as
      pre-surgical ultrasound, fine needle aspirate, and post-surgical pathology results, when
      available). All imaging assessments will be conducted by 1 blinded Nuclear Medicine
      physician. A safety evaluation will be conducted on all subjects receiving CTC, consisting of
      vital signs, haematology and SMA-12 serum biochemistry profile (pre-injection and
      post-imaging), and, for both CTC and G-PERT, an adverse event assessment (until the subject
      leaves the Nuclear Medicine department) after each administration.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Clinical Comparability of CTC with G-PERT
time frame: up to 1 year
description: The primary efficacy endpoint is the clinical comparability of CTC with G-PERT consisting of a combination of the following results:
A thyroid image, assessed for uptake or no uptake in the thyroid.
A whole body biodistribution study, assessed for uptake or no uptake in selected anatomical areas.
measure: Change in vital signs after CTC injection
time frame: Before CTC injection and after CTC scan (within ~30 min)
description: Vital signs are measured before injection of CTC and after CTC scan and changes will be summarized.
measure: Changes in haematology / SMA-12 serum biochemistry after CTC injection
time frame: Before CTC injection and after CTC scan (within ~30 min)
description: A blood sample is drawn before injection of CTC and after CTC scan. The haematology and SMA-12 serum biochemistry parameters will be recorded and all changes will be summarized.
measure: Number of participants with adverse events
time frame: up to 1 year
description: Subjects will be monitored for adverse events after CTC and G-PERT scans while in the Nuclear Medicine Department. All adverse events observed or reported will be recorded and assessed.
measure: Correlation of CTC with other clinical findings
time frame: up to 1 year
description: Correlation of thyroid images with other clinical findings (such as pre-surgical ultrasound, FNA, and post-surgical pathology results, when available).
measure: CTC diagnostic outcomes and parameters
time frame: up to 1 year
description: Calculation of diagnostic outcomes (TP, TN, FP, FN) and the corresponding diagnostic parameters (sensitivity, specificity, accuracy).
measure: Overall clinical comparability of CTC with G-PERT
time frame: up to 1 year
description: The overall clinical comparability of CTC with G-PERT using diagnostic outcomes (True Positive, True Negative, False Positive, False Negative) to determine the corresponding diagnostic parameters (sensitivity, specificity, accuracy).
arm group label: CTC and G-PERT Imaging
arm group type: Experimental
description: One experimental (CTC) and one standard (G-PERT) scan, at least 48 hours apart, before thyroid surgery. The order of the scans will be randomized.
intervention type: Drug
intervention name: CTC
description: After injection of CTC, a whole body and thyroid scan will be performed.
arm group label: CTC and G-PERT Imaging
other name: Cyclotron-produced technetium
intervention type: Drug
intervention name: G-PERT
description: After injection of G-PERT, a whole body and thyroid scan will be performed.
arm group label: CTC and G-PERT Imaging
other name: Generator-produced technetium
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Todd P McMullen, MD, PhD, FRCSC, FACS
role: Principal Investigator
affiliation: Associate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Thyroid Diseases
sharing ipd: No