<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/NCT03232632</url>
  </required_header>
  <id_info>
    <org_study_id>13 199 02</org_study_id>
    <nct_id>NCT03232632</nct_id>
  </id_info>
  <brief_title>Assessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries.</brief_title>
  <acronym>AMYLCAR</acronym>
  <official_title>Assessment of Cardiac Fixation During Positron Emission Tomography (PET) Examination Using 18F-Flutemetamol (Vizamyl ®) Within Amyloid Cardiac Injuries.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium&#xD;
      for patients with amyloid cardiac injuries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis had been performed that PET with 18F-Flutemetamol (Vizamyl®) could lead an early&#xD;
      diagnostic. Indeed, this tracer had been recently used to highlight inter-cerebral&#xD;
      beta-amyloid plaques on patients with Alzheimer Disease.&#xD;
&#xD;
      Because this labelling is performed on amyloid deposits, this tracer would lead to view and&#xD;
      to quantify amyloid deposits within cardiac amyloid injuries.&#xD;
&#xD;
      Results of this PET will be combined with scan examinations for a better anatomic tracking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    intervention programming&#xD;
  </why_stopped>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">September 15, 2019</completion_date>
  <primary_completion_date type="Actual">September 15, 2019</primary_completion_date>
  <phase>Early Phase 1</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ratio Heart/ Upper Mediastinum</measure>
    <time_frame>average of last 15 minutes</time_frame>
    <description>peak of 18F-Flutemetamol capture</description>
  </primary_outcome>
  <primary_outcome>
    <measure>standardized uptake value (SUV) measures</measure>
    <time_frame>average of last 15 minutes</time_frame>
    <description>standardized uptake value (SUV) measures</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Cardiac Amyloidosis</condition>
  <arm_group>
    <arm_group_label>PET with 18 F-Flutemetamol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PET with 18 F-Flutemetamol (Vizamyl®) = product under Alzheimer's disease indication</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PET with 18 F-Flutemetamol</intervention_name>
    <description>PET with 18 F-Flutemetamol (Vizamyl ®)</description>
    <arm_group_label>PET with 18 F-Flutemetamol</arm_group_label>
    <other_name>Vizamyl®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients followed for amyloidosis with proved cardiac injury or strongly suspected:&#xD;
&#xD;
               -  cardiac echography with typical signs of amyloid injury,&#xD;
&#xD;
               -  anatomical result confirming presence of amyloid deposits at cardiac or&#xD;
                  peripheral level&#xD;
&#xD;
          -  Signature of Informed Consent Form,&#xD;
&#xD;
          -  Affiliation to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who suffers from another pathology which could lead cardiac injury (coronary&#xD;
             disease, valvular disease, other pathology of deposit),&#xD;
&#xD;
          -  Pregnancy and lactating women,&#xD;
&#xD;
          -  Absence of effective contraception,&#xD;
&#xD;
          -  Irradiating examination performed within the last 12 months or scheduled within the&#xD;
             next 12 months,&#xD;
&#xD;
          -  Unable patient physically, mentally or legally to provide informed consent,&#xD;
&#xD;
          -  Patient under a system of legal protection&#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>Eric OUHAYOUN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>August 24, 2020</last_update_submitted>
  <last_update_submitted_qc>August 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amyloidosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Flutemetamol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03232632
org study id: 13 199 02
nct id: NCT03232632
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium
      for patients with amyloid cardiac injuries.
Hypothesis had been performed that PET with 18F-Flutemetamol (Vizamyl®) could lead an early
      diagnostic. Indeed, this tracer had been recently used to highlight inter-cerebral
      beta-amyloid plaques on patients with Alzheimer Disease.

      Because this labelling is performed on amyloid deposits, this tracer would lead to view and
      to quantify amyloid deposits within cardiac amyloid injuries.

      Results of this PET will be combined with scan examinations for a better anatomic tracking.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: ratio Heart/ Upper Mediastinum
time frame: average of last 15 minutes
description: peak of 18F-Flutemetamol capture
measure: standardized uptake value (SUV) measures
time frame: average of last 15 minutes
description: standardized uptake value (SUV) measures
arm group label: PET with 18 F-Flutemetamol
arm group type: Experimental
description: PET with 18 F-Flutemetamol (Vizamyl®) = product under Alzheimer's disease indication
intervention type: Drug
intervention name: PET with 18 F-Flutemetamol
description: PET with 18 F-Flutemetamol (Vizamyl ®)
arm group label: PET with 18 F-Flutemetamol
other name: Vizamyl®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric OUHAYOUN, MD
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: Amyloidosis
mesh term: Flutemetamol
sharing ipd: No