<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/NCT01681524</url>
  </required_header>
  <id_info>
    <org_study_id>BMS747158-302</org_study_id>
    <nct_id>NCT01681524</nct_id>
  </id_info>
  <brief_title>Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI</brief_title>
  <official_title>A Phase 3, Open Label, Multicenter Study for the Assessment of Myocardial Perfusion Using Positron Emission Tomography (PET) Imaging of Flurpiridaz F18 Injection in Patients With Suspected or Known Coronary Artery Disease (CAD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lantheus Medical Imaging</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lantheus Medical Imaging</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to&#xD;
      determine if the study drug in PET imaging is better than SPECT imaging currently used for&#xD;
      this purpose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz&#xD;
      F18 Injection MPI in comparison with SPECT MPI in patients with known or suspected CAD. Six&#xD;
      hundred and seventy-two evaluable patients will be enrolled and will undergo SPECT MPI and&#xD;
      Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to&#xD;
      undergo or have undergone prior ICA without intervention (being either positive or negative&#xD;
      for CAD).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    delayed study start&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">May 2014</completion_date>
  <primary_completion_date type="Anticipated">February 2014</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>Blinded Image assessment for PET &amp; SPECT perfusion and for interventional coronary angiography</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic performance evaluation of CAD (PETVsSPECT)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnositic performance evaluation of multivessel disease (PETvsSPECT)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection of CAD in subgroups: pharm stress, females and BMI&gt;/=30</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Image quality of rest and stress (PETvsSPECT)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic certainty evaluation of rest and stress (PETvsSPECT)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of reversible defect size of rest and stress (PETvsSPECT)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety evaluation of flurpiridaz F 18 will include monitoring the number participants with adverse events (AEs), medication errors, treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs).</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Flurpiridaz F18</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open-label study of a single injection of flurpiridaz F18 for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary cathertization</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flurpiridaz F18</intervention_name>
    <description>Injection of Flurpiridaz F18 for the purposes of PET MPI analysis</description>
    <arm_group_label>Flurpiridaz F18</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Invasive Coronary Angiography Men or Women age 18 or older - see protocol for additional&#xD;
        details&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Women who are pregnant, lactating, or of child bearing potential who are not practicing&#xD;
        birth control Unstable cardiac status History of coronary artery bypass graft History of&#xD;
        PCI within the past six months See protocol for additional details&#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>Cesare Orlandi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Lantheus Medical Imaging</affiliation>
  </overall_official>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>May 29, 2013</last_update_submitted>
  <last_update_submitted_qc>May 29, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 30, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Flurpiridaz F18 Injection</keyword>
  <keyword>Positron Emission Tomography Myocardial Perfusion Imaging</keyword>
  <keyword>Single Positron Emission Computed Tomography</keyword>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Myocardia Ischemia</keyword>
  <keyword>Coronary Disease</keyword>
  <keyword>Heart Diseases</keyword>
  <keyword>Cardiovascular Diseases</keyword>
  <keyword>Arteriosclerosis</keyword>
  <keyword>Arterial Occlusive Diseases</keyword>
  <keyword>Vascular Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01681524
org study id: BMS747158-302
nct id: NCT01681524
lead sponsor: 
has dmc: Yes
The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to
      determine if the study drug in PET imaging is better than SPECT imaging currently used for
      this purpose.
The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz
      F18 Injection MPI in comparison with SPECT MPI in patients with known or suspected CAD. Six
      hundred and seventy-two evaluable patients will be enrolled and will undergo SPECT MPI and
      Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to
      undergo or have undergone prior ICA without intervention (being either positive or negative
      for CAD).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography
time frame: 12 months
measure: Diagnostic performance evaluation of CAD (PETVsSPECT)
time frame: 12 months
measure: Diagnositic performance evaluation of multivessel disease (PETvsSPECT)
time frame: 12 months
measure: Detection of CAD in subgroups: pharm stress, females and BMI>/=30
time frame: 12 months
measure: Image quality of rest and stress (PETvsSPECT)
time frame: 12 months
measure: Diagnostic certainty evaluation of rest and stress (PETvsSPECT)
time frame: 12 months
measure: Evaluation of reversible defect size of rest and stress (PETvsSPECT)
time frame: 12 months
measure: Safety evaluation of flurpiridaz F 18 will include monitoring the number participants with adverse events (AEs), medication errors, treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs).
time frame: 12 months
arm group label: Flurpiridaz F18
arm group type: Experimental
description: Open-label study of a single injection of flurpiridaz F18 for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary cathertization
intervention type: Drug
intervention name: Flurpiridaz F18
description: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
arm group label: Flurpiridaz F18
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cesare Orlandi, MD
role: Study Director
affiliation: Lantheus Medical Imaging
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease