<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/NCT03275584</url>
  </required_header>
  <id_info>
    <org_study_id>17.015</org_study_id>
    <nct_id>NCT03275584</nct_id>
  </id_info>
  <brief_title>Safety of PET MPI Using the CRCHUM N-13 Ammonia</brief_title>
  <official_title>Sûreté de la Perfusion Myocardique Par la Tomographie d'émission Par Positron Avec l'Ammoniaque marqué au N-13 du Centre de Recherche du Centre Hospitalier de l'Université de Montréal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Positron emission tomography (PET) myocardial perfusion imaging (MPI) is an examination that&#xD;
      helps to assess the function and perfusion of the heart. Completion of this examination&#xD;
      requires the injection of a small dose of a radiotracer (a radioactive substance).&#xD;
&#xD;
      PET MPI is a state-of-the-art non-invasive cardiac imaging tool. The main goal of the PET MPI&#xD;
      examination is to assess if one or more of the arteries feeding blood to your heart are&#xD;
      blocked. This examination replaces an older technology (single photon emission computed&#xD;
      tomography, or SPECT), and allows the obtention of more accurate information, and new&#xD;
      information that the older SPECT technology did not assess. The radiation dose received as&#xD;
      part of the procedure is also smaller with PET versus SPECT.&#xD;
&#xD;
      One of the substances which can be used for PET MPI is called N-13 ammoniac (NH3). For this&#xD;
      clinical study, NH3 which will be produced at the Centre de Recherche du Centre Hospitalier&#xD;
      de l'Université de Montréal (CRCHUM), per the standards and methods prescribed by Health&#xD;
      Canada. NH3 is not currently approved for clinical use by Health Canada. It is thus&#xD;
      considered and experimental substance in the context of this study.&#xD;
&#xD;
      Participants will undergo PET MPI with the CRCHUM NH3. The PET MPI procedure itself is not an&#xD;
      experimental procedure and is not part of the research protocol. Only the use of NH3 produced&#xD;
      at the CRCHUM is experimental.&#xD;
&#xD;
      The main objective of this research study is to validate the production process and assess&#xD;
      the safety of the NH3 produced at the CRCHUM cyclotron. Secondary objectives include the&#xD;
      assessment of prescription practices amongst physicians who refer patients for PET MPI, and&#xD;
      how they will change over time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 30, 2018</start_date>
  <completion_date type="Anticipated">January 2028</completion_date>
  <primary_completion_date type="Anticipated">January 2028</primary_completion_date>
  <phase>Phase 4</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>Adverse reaction to the N-13 ammonia injection</measure>
    <time_frame>1 hour</time_frame>
    <description>The absence or presence of adverse reactions related to the N-13 ammonia injection, as a simple yes or no.&#xD;
The following tools will be used to establish the presence/absence of adverse reaction:&#xD;
Questionnaire during and after the procedure&#xD;
Vital signs monitoring before, during and after the procedure&#xD;
Patient's self-reported side-effects from the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of specific adverse reactions to N-13 ammonia injection</measure>
    <time_frame>1 hour</time_frame>
    <description>If any adverse reactions to the N-13 ammonia injection are reported (see Primary Outcome), the incidence of specific adverse reactions will be recorded and calculated.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20000</enrollment>
  <condition>N-13 Ammonia Safety</condition>
  <arm_group>
    <arm_group_label>Main arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>N-13 ammonia intravenous injection; 2 injections, 3-7 MBq/kg per injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N-13 ammonia intravenous injection</intervention_name>
    <description>Participants will receive two injections of N-13 ammonia, once at &quot;rest&quot; and once at &quot;stress&quot; before undergoing positron emission tomography myocardial perfusion imaging</description>
    <arm_group_label>Main arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient being referred for clinically indicated positron emission tomography&#xD;
             myocardial perfusion imaging at the Centre hospitalier de l'Université de Montréal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Claustrophobic patient unable to undergo the examination&#xD;
&#xD;
          -  Breastfeeding women unwilling to temporarily stop breastfeeding&#xD;
&#xD;
          -  Patient with contra-indication to: dipyridamole, aminophylline, dobutamine or exercise&#xD;
             stress test (depending on the method of cardiovascular stress test chosen)&#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>Daniel Juneau, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel Juneau, MD</last_name>
    <phone>1-514-890-8180</phone>
    <email>daniel.juneau@umontreal.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Hospitalier de l'université de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 0C1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>positron emission tomography</keyword>
  <keyword>NH3</keyword>
  <!-- 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/NCT03275584
org study id: 17.015
nct id: NCT03275584
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Positron emission tomography (PET) myocardial perfusion imaging (MPI) is an examination that
      helps to assess the function and perfusion of the heart. Completion of this examination
      requires the injection of a small dose of a radiotracer (a radioactive substance).

      PET MPI is a state-of-the-art non-invasive cardiac imaging tool. The main goal of the PET MPI
      examination is to assess if one or more of the arteries feeding blood to your heart are
      blocked. This examination replaces an older technology (single photon emission computed
      tomography, or SPECT), and allows the obtention of more accurate information, and new
      information that the older SPECT technology did not assess. The radiation dose received as
      part of the procedure is also smaller with PET versus SPECT.

      One of the substances which can be used for PET MPI is called N-13 ammoniac (NH3). For this
      clinical study, NH3 which will be produced at the Centre de Recherche du Centre Hospitalier
      de l'Université de Montréal (CRCHUM), per the standards and methods prescribed by Health
      Canada. NH3 is not currently approved for clinical use by Health Canada. It is thus
      considered and experimental substance in the context of this study.

      Participants will undergo PET MPI with the CRCHUM NH3. The PET MPI procedure itself is not an
      experimental procedure and is not part of the research protocol. Only the use of NH3 produced
      at the CRCHUM is experimental.

      The main objective of this research study is to validate the production process and assess
      the safety of the NH3 produced at the CRCHUM cyclotron. Secondary objectives include the
      assessment of prescription practices amongst physicians who refer patients for PET MPI, and
      how they will change over time.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Adverse reaction to the N-13 ammonia injection
time frame: 1 hour
description: The absence or presence of adverse reactions related to the N-13 ammonia injection, as a simple yes or no.
The following tools will be used to establish the presence/absence of adverse reaction:
Questionnaire during and after the procedure
Vital signs monitoring before, during and after the procedure
Patient's self-reported side-effects from the procedure
measure: Incidence of specific adverse reactions to N-13 ammonia injection
time frame: 1 hour
description: If any adverse reactions to the N-13 ammonia injection are reported (see Primary Outcome), the incidence of specific adverse reactions will be recorded and calculated.
arm group label: Main arm
arm group type: Experimental
description: N-13 ammonia intravenous injection; 2 injections, 3-7 MBq/kg per injection
intervention type: Drug
intervention name: N-13 ammonia intravenous injection
description: Participants will receive two injections of N-13 ammonia, once at "rest" and once at "stress" before undergoing positron emission tomography myocardial perfusion imaging
arm group label: Main arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Juneau, MD
role: Principal Investigator
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
last name: Daniel Juneau, MD
phone: 1-514-890-8180
email: daniel.juneau@umontreal.ca
facility: 
status: Recruiting
country: Canada
responsible party type: Sponsor