<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/NCT02252783</url>
  </required_header>
  <id_info>
    <org_study_id>BFPET P-02</org_study_id>
    <nct_id>NCT02252783</nct_id>
  </id_info>
  <brief_title>BFPET for Regional Myocardial Perfusion Imaging</brief_title>
  <official_title>A Phase II Open-Labeled Study to Evaluate BFPET as a Myocardial Perfusion Imaging Agent for the Evaluation of Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fluoropharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fluoropharma, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      BFPET will be evaluated as a diagnostic PET agent for assessing myocardial perfusion in&#xD;
      subjects with known or suspected coronary artery disease (CAD) as compared to standard&#xD;
      nuclear myocardial perfusion imaging (MPI). The safety of BFPET will be evaluated in known or&#xD;
      suspected CAD subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2019</primary_completion_date>
  <phase>Phase 2</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>Sensitivity and specificity of BFPET</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>To evaluate the diagnostic performance of BFPET as a PET agent assessment of myocardial perfusion in known or suspected CAD subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary safety endpoints - ECG, physical examinations, vital signs, laboratory and adverse event assessments</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>Vital signs, ECG, laboratory assessments - up to 24 hours post injection, adverse event assessment at all study visits (7-10 days) post BFPET administration</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>BFPET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BFPET will be administered as a single intravenous injection of up to 2 mCi (74 MBq) at rest and a single intravenous injection of up to 8mCi (296 MBq) following a stress protocol. Total amount not to exceed 10mCi (370 MBq).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BFPET</intervention_name>
    <description>Sterile study drug will be delivered in individual dosage vials labeled and calibrated to approximately 2 mCi (74MBq) for the rest imaging and up to 8 mCi (296 MBq) for the stress imaging at the time of injection. The drug will be administered intravenously by bolus injection over 10 seconds into a peripheral vein to which access has been secured followed by saline flush.</description>
    <arm_group_label>BFPET</arm_group_label>
    <other_name>FTPP FluorophenylTriPhenylPhosphonium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must provide written informed consent prior to any study related procedures;&#xD;
&#xD;
          -  Subjects must be ≥ 21 and ≤ 85 years of age;&#xD;
&#xD;
          -  Subjects must have known or suspected CAD documented by ≥2 segments of reversible&#xD;
             perfusion abnormalities on a SPECT (MPI)study&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Any clinically significant acute or unstable physical or psychological disease judged&#xD;
             by the investigators based on medical history or screening physical examination;&#xD;
&#xD;
          -  Blood pressure over 180/100mmHg&#xD;
&#xD;
          -  Acute changes in comparison to most recent ECG;&#xD;
&#xD;
          -  Recent (within 3 months) cardiac arrest, unstable angina, cerebro-vascular accident&#xD;
             (CVA), CABG or PCI&#xD;
&#xD;
          -  Any pacemaker or defibrillator implanted within the last three months;&#xD;
&#xD;
          -  Inability to remain in camera for approximately 60 minutes&#xD;
&#xD;
          -  Bronchospasm&#xD;
&#xD;
          -  Serum creatinine &gt; 2 mg/dL;&#xD;
&#xD;
          -  Cancer patients who have received chemotherapy or radiation therapy within the past 60&#xD;
             days.&#xD;
&#xD;
          -  Any exposure to any investigational drug(s) or medical device(s) within four (4) weeks&#xD;
             prior to imaging study;&#xD;
&#xD;
          -  Any physical or psychological disease judged by the investigators to be incompatible&#xD;
             with the study, based on medical history or screening physical examination.&#xD;
&#xD;
          -  NYHA Class III or IV Congestive heart failure;&#xD;
&#xD;
          -  Subject has symptomatic hypotension&#xD;
&#xD;
          -  Allergic or intolerant to aminophylline, nitroglycerin or metoprolol&#xD;
&#xD;
          -  Allergic or intolerant to regadenoson or any of its excipients&#xD;
&#xD;
          -  Prior participants in the study.&#xD;
&#xD;
          -  Female subjects only: Positive serum and/or urine pregnancy test or is lactating or&#xD;
             the possibility of pregnancy cannot be ruled out prior to dosing.&#xD;
&#xD;
        Females not of child-bearing potential require confirmatory documentation in their medical&#xD;
        records or must have a negative pregnancy test within 4 hours prior to receiving the test&#xD;
        drug and agree to use an acceptable form of birth control for at least 30 days following&#xD;
        BFPET administration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Georges El Fakhri, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ed Lyons</last_name>
    <phone>973-744-1565</phone>
    <email>ELyons@Fluoropharma.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>July 31, 2018</last_update_submitted>
  <last_update_submitted_qc>July 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Myocardial 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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02252783
org study id: BFPET P-02
nct id: NCT02252783
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
BFPET will be evaluated as a diagnostic PET agent for assessing myocardial perfusion in
      subjects with known or suspected coronary artery disease (CAD) as compared to standard
      nuclear myocardial perfusion imaging (MPI). The safety of BFPET will be evaluated in known or
      suspected CAD subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity and specificity of BFPET
time frame: Up to 30 days
description: To evaluate the diagnostic performance of BFPET as a PET agent assessment of myocardial perfusion in known or suspected CAD subjects.
measure: Primary safety endpoints - ECG, physical examinations, vital signs, laboratory and adverse event assessments
time frame: Up to 10 days
description: Vital signs, ECG, laboratory assessments - up to 24 hours post injection, adverse event assessment at all study visits (7-10 days) post BFPET administration
arm group label: BFPET
arm group type: Experimental
description: BFPET will be administered as a single intravenous injection of up to 2 mCi (74 MBq) at rest and a single intravenous injection of up to 8mCi (296 MBq) following a stress protocol. Total amount not to exceed 10mCi (370 MBq).
intervention type: Drug
intervention name: BFPET
description: Sterile study drug will be delivered in individual dosage vials labeled and calibrated to approximately 2 mCi (74MBq) for the rest imaging and up to 8 mCi (296 MBq) for the stress imaging at the time of injection. The drug will be administered intravenously by bolus injection over 10 seconds into a peripheral vein to which access has been secured followed by saline flush.
arm group label: BFPET
other name: FTPP FluorophenylTriPhenylPhosphonium
criteria: 
gender: All
minimum age: 21 Years
maximum age: 85 Years
healthy volunteers: No
last name: Georges El Fakhri, Ph.D.
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Ed Lyons
phone: 973-744-1565
email: ELyons@Fluoropharma.com
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: Undecided