<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/NCT03002454</url>
  </required_header>
  <id_info>
    <org_study_id>NA 99Mo 001</org_study_id>
    <nct_id>NCT03002454</nct_id>
  </id_info>
  <brief_title>Sodium Pertechnetate (99Tc) Injection Generator: 99mTc From Neutron-activation 99Mo v 99mTc From Fission 99Mo</brief_title>
  <official_title>A Cross-over Comparison of the Diagnostic Accuracy of Technetium (99mTc) Medronate Injection Prepared With 99mTc Derived From Neutron-activation Produced 99Mo Versus the Current Reference Standard of 99mTc Derived From Fission-produced 99Mo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Winnipeg Regional Health Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A non-fission sourced, solvent generator produced 99mTc intravenous injection, as 99mTc -MDP,&#xD;
      is to be used as a bone scan diagnostic radiopharmaceutical for assessment of bone pathology&#xD;
      using the same oncologic indications as nuclear reactor sourced 99mTc, as 99mTc-MDP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial will be a comparison of diagnostic and imaging equivalency of 99mTc&#xD;
      Pertechnetate intravenous injection (labeled with commercial MDP kits) produced by a&#xD;
      non-fission sourced/solvent generator and a nuclear reactor/column sourced generator. Each&#xD;
      oncologic participant acts as their own control to reduce error variance.&#xD;
&#xD;
      Condition Intervention Phase Oncologic indication for which a bone scan would normally be&#xD;
      indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate&#xD;
      Injection USP labeled with 99mTc derived from fission-sourced 99Mo. Drug: Technetium (99mTc)&#xD;
      Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.&#xD;
      Phase 3&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Altered biodistribution in investigational images versus standard images.&#xD;
  </why_stopped>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Number of Participants Analyzed for Diagnostic Efficacy of Technetium (99mTc) Medronate Injection Prepared With 99mTc Derived From Neutron-activation Produced 99Mo Imaging Sensitivity Versus 99mTc Derived From Fission-produced 99Mo Imaging Sensitivity.</measure>
    <time_frame>60 days</time_frame>
    <description>All enrolled patients were re-imaged 3 to 28 days post a standard of care fission derived 99Mo bone scan using neutron-activation produced 99Mo as the investigational product. Per protocol dosage, time factors, injection site and imaging camera were matched. Resulting image sets (fission and neutron-activation) were analyzed visually for concordant biodistribution.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Cancer of Bone</condition>
  <arm_group>
    <arm_group_label>99mTc MDP Injection:neutron-bombardment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo. The images of the 99mTc MDP Injection-neutron-bombardment will be compared to the previous (on file) images from the 99mTc MDP Injection-fission</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>99mTc MDP Injection:neutron-bombardment</intervention_name>
    <description>Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.</description>
    <arm_group_label>99mTc MDP Injection:neutron-bombardment</arm_group_label>
    <other_name>Sodium Pertechnetate (99Tc) Injection Generator (neutron)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Oncology out-patients in whom an acceptable quality standard-of-care Technetium&#xD;
             (99mTc) Medronate bone scan has been ordered or obtained within the last 28 days.&#xD;
&#xD;
          -  If female of child-bearing potential is outside of the window of 10 days since the&#xD;
             last menstrual period, a negative serum pregnancy test is required.&#xD;
&#xD;
          -  Age greater than or equal to 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Oncology out-patients in whom an acceptable quality standard-of-care Technetium&#xD;
             (99mTc) Medronate bone scan has been ordered or obtained within the last 28 days.&#xD;
&#xD;
          -  If female of child-bearing potential is outside of the window of 10 days since the&#xD;
             last menstrual period, a negative serum pregnancy test is required.&#xD;
&#xD;
          -  Age greater than or equal to 18 years.&#xD;
&#xD;
          -  Identified interval events which have occurred after the standard of care bone scan&#xD;
             but prior to the administration of non-fission sourced Technetium (99mTc) Medronate&#xD;
             which could influence or change bone scan uptake (e.g. skeletal trauma, orthopedic&#xD;
             surgery, bone infection, or interval therapy (i.e. radiation therapy, non-maintenance&#xD;
             chemotherapy). -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandor J Demeter, MSc MD FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Winnipeg Regional Health Authority</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Sciences Centre</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <results_first_submitted>January 13, 2017</results_first_submitted>
  <results_first_submitted_qc>May 3, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 3, 2017</results_first_posted>
  <last_update_submitted>May 3, 2017</last_update_submitted>
  <last_update_submitted_qc>May 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>Dr. Sandor J. Demeter</investigator_full_name>
    <investigator_title>Head, Nuclear Medicine</investigator_title>
  </responsible_party>
  <keyword>99mTc Pertechnetate</keyword>
  <keyword>Sodium Pertechnetate</keyword>
  <keyword>Technetium</keyword>
  <keyword>Molybdenum</keyword>
  <keyword>MDP</keyword>
  <keyword>neutron activation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sodium Pertechnetate Tc 99m</mesh_term>
    <mesh_term>Technetium Tc 99m Medronate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Oncologic bone imaging subjects screened and enrolled at Health Sciences Centre, Winnipeg, Manitoba from August to November 2017.</recruitment_details>
      <pre_assignment_details>Previous bone imaging scan, within 3 to 28 days, using fission derived 99mTc MDP Injection to act as comparator for investigative drug (neutron-bombardment derived 99mTc MDP Injection) bone imaging scan of same subject.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>99mTc MDP Injection:Neutron-bombardment</title>
          <description>Oncologic indication for which a bone scan would normally be indicated. All 4 participants initially had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.&#xD;
3-28 days later all participants had a second bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>99mTc MDP Injection:Neutron-bombardment</title>
          <description>Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.&#xD;
99mTc MDP Injection:neutron-bombardment: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.5" lower_limit="44" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Analyzed for Diagnostic Efficacy of Technetium (99mTc) Medronate Injection Prepared With 99mTc Derived From Neutron-activation Produced 99Mo Imaging Sensitivity Versus 99mTc Derived From Fission-produced 99Mo Imaging Sensitivity.</title>
        <description>All enrolled patients were re-imaged 3 to 28 days post a standard of care fission derived 99Mo bone scan using neutron-activation produced 99Mo as the investigational product. Per protocol dosage, time factors, injection site and imaging camera were matched. Resulting image sets (fission and neutron-activation) were analyzed visually for concordant biodistribution.</description>
        <time_frame>60 days</time_frame>
        <population>Each participant (4) acted as their own control to reduce variance. Paired image sets were analyzed visually for concordant biodistribution between the 99mTc Medronate Injection prepared with 99mTc derived from Neutron-activation produced 99Mo versus 99mTc Medronate Injection derived from Fission-produced 99Mo referenced as the baseline standard.</population>
        <group_list>
          <group group_id="O1">
            <title>99mTc MDP Injection:Neutron-bombardment</title>
            <description>Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.&#xD;
99mTc MDP Injection:neutron-bombardment: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Analyzed for Diagnostic Efficacy of Technetium (99mTc) Medronate Injection Prepared With 99mTc Derived From Neutron-activation Produced 99Mo Imaging Sensitivity Versus 99mTc Derived From Fission-produced 99Mo Imaging Sensitivity.</title>
          <description>All enrolled patients were re-imaged 3 to 28 days post a standard of care fission derived 99Mo bone scan using neutron-activation produced 99Mo as the investigational product. Per protocol dosage, time factors, injection site and imaging camera were matched. Resulting image sets (fission and neutron-activation) were analyzed visually for concordant biodistribution.</description>
          <population>Each participant (4) acted as their own control to reduce variance. Paired image sets were analyzed visually for concordant biodistribution between the 99mTc Medronate Injection prepared with 99mTc derived from Neutron-activation produced 99Mo versus 99mTc Medronate Injection derived from Fission-produced 99Mo referenced as the baseline standard.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Control: 99mTc MDP Injection:fission Investigation: 99mTc MDP Injection:neutron-bombardment&#xD;
Anticipated sample size of 50 participants with sample size parameters of:&#xD;
Alpha 0.05 Power 80% Kappa of significance 0.7 - 0.8 Prevalence of abnormal bone scans 30%&#xD;
Actual study population of 4 participants with 4 out of 4 demonstrating gross abnormal biodistribution therefore the study was terminated and no statistical analysis was conducted.</non_inferiority_desc>
            <other_analysis_desc>No statistical analysis - insufficient study population</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Reported Adverse Events (AEs) for the overall study include events starting on or after study start date and on or before study close date.</time_frame>
      <desc>Safety population included all participants who received investigational product 99mTc MDP Injection derived from neutron-bombardment. Safety assessments: telephone interview at 14 days, chart check at 30 days.</desc>
      <group_list>
        <group group_id="E1">
          <title>99mTc MDP Injection:Fission</title>
          <description>Oncologic indication for which a bone scan would normally be indicated.&#xD;
99mTc MDP Injection:fission: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.</description>
        </group>
        <group group_id="E2">
          <title>99mTc MDP Injection:Neutron-bombardment</title>
          <description>Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.&#xD;
99mTc MDP Injection:neutron-bombardment: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination. Despite a relatively comprehensive review of the first four subject's bone imaging scans a cause of an observed altered biodistribution is not apparent. As such study recruitment will be terminated.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Sandor Demeter</name_or_title>
      <organization>Winnipeg Regional Health Authority</organization>
      <phone>1 (204) 787-3375</phone>
      <email>sdemeter@hsc.mb.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03002454
org study id: NA 99Mo 001
nct id: NCT03002454
lead sponsor: 
collaborator: 
has dmc: No
A non-fission sourced, solvent generator produced 99mTc intravenous injection, as 99mTc -MDP,
      is to be used as a bone scan diagnostic radiopharmaceutical for assessment of bone pathology
      using the same oncologic indications as nuclear reactor sourced 99mTc, as 99mTc-MDP.
This clinical trial will be a comparison of diagnostic and imaging equivalency of 99mTc
      Pertechnetate intravenous injection (labeled with commercial MDP kits) produced by a
      non-fission sourced/solvent generator and a nuclear reactor/column sourced generator. Each
      oncologic participant acts as their own control to reduce error variance.

      Condition Intervention Phase Oncologic indication for which a bone scan would normally be
      indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate
      Injection USP labeled with 99mTc derived from fission-sourced 99Mo. Drug: Technetium (99mTc)
      Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.
      Phase 3
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Participants Analyzed for Diagnostic Efficacy of Technetium (99mTc) Medronate Injection Prepared With 99mTc Derived From Neutron-activation Produced 99Mo Imaging Sensitivity Versus 99mTc Derived From Fission-produced 99Mo Imaging Sensitivity.
time frame: 60 days
description: All enrolled patients were re-imaged 3 to 28 days post a standard of care fission derived 99Mo bone scan using neutron-activation produced 99Mo as the investigational product. Per protocol dosage, time factors, injection site and imaging camera were matched. Resulting image sets (fission and neutron-activation) were analyzed visually for concordant biodistribution.
arm group label: 99mTc MDP Injection:neutron-bombardment
arm group type: Experimental
description: Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo. The images of the 99mTc MDP Injection-neutron-bombardment will be compared to the previous (on file) images from the 99mTc MDP Injection-fission
intervention type: Drug
intervention name: 99mTc MDP Injection:neutron-bombardment
description: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.
arm group label: 99mTc MDP Injection:neutron-bombardment
other name: Sodium Pertechnetate (99Tc) Injection Generator (neutron)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sandor J Demeter, MSc MD FRCPC
role: Principal Investigator
affiliation: Winnipeg Regional Health Authority
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: Dr. Sandor J. Demeter
investigator title: Head, Nuclear Medicine
mesh term: Bone Neoplasms
mesh term: Sodium Pertechnetate Tc 99m
mesh term: Technetium Tc 99m Medronate
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination. Despite a relatively comprehensive review of the first four subject's bone imaging scans a cause of an observed altered biodistribution is not apparent. As such study recruitment will be terminated.
point of contact: 