<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/NCT03040427</url>
  </required_header>
  <id_info>
    <org_study_id>16-960</org_study_id>
    <nct_id>NCT03040427</nct_id>
  </id_info>
  <brief_title>The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis</brief_title>
  <official_title>The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Avid Radiopharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</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>
      The investigators postulate that F-18 florbetapir will show improved detection of cardiac&#xD;
      amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      F-18 florbetapir is currently used for the early detection of brain amyloid (Alzheimer's&#xD;
      disease). The hypothesis is that F-18 florbetapir will detect amyloid deposition in&#xD;
      myocardium prior to current non-invasive diagnostic measures, particular electrocardiography&#xD;
      with strain and technetium pyrophosphate scintigraphy. The investigators intend to use F-18&#xD;
      florbetapir and assess its correlation between standard non-invasive diagnostic modalities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">August 21, 2019</completion_date>
  <primary_completion_date type="Actual">August 21, 2019</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>Quantitative Myocardial F18-florbetapir Uptake</measure>
    <time_frame>at the time of the PET scan</time_frame>
    <description>Number of participants with quantitative F18-florbetapir uptake above previously defined control values</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Cardiac Amyloidosis</condition>
  <arm_group>
    <arm_group_label>AL or TTR type amyloidosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants will undergo F-18 florbetapir PET scan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>F-18 florbetapir</intervention_name>
    <description>Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid).</description>
    <arm_group_label>AL or TTR type amyloidosis</arm_group_label>
    <other_name>Amyvid</other_name>
    <other_name>Florbetapir-fluorine-18</other_name>
    <other_name>18F-AV-45</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis&#xD;
&#xD;
          2. Patients with a ratio of affected to unaffected free light chains &gt;5 or free light&#xD;
             chain difference of &gt;50&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall&#xD;
             thickness ≥ 13mm&#xD;
&#xD;
          2. Contraindication to florbetapir or its components&#xD;
&#xD;
          3. Refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Nissen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wael Jaber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation (Main Campus)</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>May 11, 2021</results_first_submitted>
  <results_first_submitted_qc>July 7, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 27, 2021</results_first_posted>
  <last_update_submitted>July 7, 2021</last_update_submitted>
  <last_update_submitted_qc>July 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>F-18 florbetapir</keyword>
  <keyword>Amyvid</keyword>
  <keyword>PET scan</keyword>
  <keyword>Early detection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amyloidosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 22, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03040427/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>At Risk for Symptomatic AL Cardiac Amyloidosis</title>
          <description>Patients with MGUS at risk for developing AL amyloidosis</description>
        </group>
        <group group_id="P2">
          <title>At Risk for Symptomatic ATTR Cardiac Amyloidosis</title>
          <description>Patients with biopsy proven extra-cardiac ATTR amyloidosis</description>
        </group>
        <group group_id="P3">
          <title>Control Patients</title>
          <description>Negative carpal tunnel biopsy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>At Risk for Symptomatic AL Cardiac Amyloidosis</title>
          <description>Patients with MGUS at risk for developing AL amyloidosis</description>
        </group>
        <group group_id="B2">
          <title>At Risk for Symptomatic ATTR Cardiac Amyloidosis</title>
          <description>Patients with biopsy proven extra-cardiac ATTR amyloidosis</description>
        </group>
        <group group_id="B3">
          <title>Control Patients</title>
          <description>Negative carpal tunnel biopsy</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="4"/>
            <count group_id="B4" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.5" spread="3.5"/>
                    <measurement group_id="B2" value="71.4" spread="5.2"/>
                    <measurement group_id="B3" value="72" spread="6.9"/>
                    <measurement group_id="B4" value="72" spread="5.5"/>
                  </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="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Quantitative Myocardial F18-florbetapir Uptake</title>
        <description>Number of participants with quantitative F18-florbetapir uptake above previously defined control values</description>
        <time_frame>at the time of the PET scan</time_frame>
        <population>All participants had quantitative uptake of F18-Flobetapir</population>
        <group_list>
          <group group_id="O1">
            <title>At Risk for Symptomatic AL Cardiac Amyloidosis</title>
            <description>Patients with MGUS at risk for developing AL amyloidosis</description>
          </group>
          <group group_id="O2">
            <title>At Risk for Symptomatic ATTR Cardiac Amyloidosis</title>
            <description>Patients with biopsy proven extra-cardiac ATTR amyloidosis</description>
          </group>
          <group group_id="O3">
            <title>Control Patients</title>
            <description>Negative carpal tunnel biopsy</description>
          </group>
        </group_list>
        <measure>
          <title>Quantitative Myocardial F18-florbetapir Uptake</title>
          <description>Number of participants with quantitative F18-florbetapir uptake above previously defined control values</description>
          <population>All participants had quantitative uptake of F18-Flobetapir</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="2"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>At Risk for Symptomatic AL Cardiac Amyloidosis</title>
          <description>Patients with MGUS at risk for developing AL amyloidosis</description>
        </group>
        <group group_id="E2">
          <title>At Risk for Symptomatic ATTR Cardiac Amyloidosis</title>
          <description>Patients with biopsy proven extra-cardiac ATTR amyloidosis</description>
        </group>
        <group group_id="E3">
          <title>Control Patients</title>
          <description>Negative carpal tunnel biopsy</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <point_of_contact>
      <name_or_title>Dr. Wael A. Jaber</name_or_title>
      <organization>Cleveland Clinic Foundation</organization>
      <phone>216.444.8305</phone>
      <email>jaberw@ccf.org</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/NCT03040427
org study id: 16-960
nct id: NCT03040427
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The investigators postulate that F-18 florbetapir will show improved detection of cardiac
      amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.
F-18 florbetapir is currently used for the early detection of brain amyloid (Alzheimer's
      disease). The hypothesis is that F-18 florbetapir will detect amyloid deposition in
      myocardium prior to current non-invasive diagnostic measures, particular electrocardiography
      with strain and technetium pyrophosphate scintigraphy. The investigators intend to use F-18
      florbetapir and assess its correlation between standard non-invasive diagnostic modalities.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Quantitative Myocardial F18-florbetapir Uptake
time frame: at the time of the PET scan
description: Number of participants with quantitative F18-florbetapir uptake above previously defined control values
arm group label: AL or TTR type amyloidosis
arm group type: Experimental
description: The participants will undergo F-18 florbetapir PET scan.
intervention type: Drug
intervention name: F-18 florbetapir
description: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid).
arm group label: AL or TTR type amyloidosis
other name: Amyvid
other name: Florbetapir-fluorine-18
other name: 18F-AV-45
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Steven Nissen, MD
role: Study Chair
affiliation: The Cleveland Clinic
last name: Wael Jaber, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Amyloidosis
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 