<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/NCT03809689</url>
  </required_header>
  <id_info>
    <org_study_id>68Ga-NODAGA-RGD cardiac PET</org_study_id>
    <nct_id>NCT03809689</nct_id>
  </id_info>
  <brief_title>Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET</brief_title>
  <official_title>Study of Acute and Chronic Myocardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lausanne Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Lausanne Hospitals</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>
      The study is about exploring physiological angiogenesis linked to tissue repair in patients&#xD;
      with acute heart infarction or chronic heart ischemia by means of 68Ga-NODAGA-RGD PET/CT&#xD;
      imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several animal studies have demonstrated the expression of αvβ3 integrins on the surface of&#xD;
      the endothelium present in neovessels in formation, especially during neoangiogenesis after&#xD;
      myocardial ischemic injury.&#xD;
&#xD;
      68Ga-NODAGA-RGD is a positron-emission-tomography (PET) ligand targeted towards αvβ3&#xD;
      integrins. αvβ3 integrins could potentially act as a biomarker for the follow-up of heart&#xD;
      infarction.&#xD;
&#xD;
      In the present study, 68Ga-NODAGA-RGD PET/CT imaging is a tool to understand and evaluate&#xD;
      tissue repair after heart lesion and its evolution allowing a better management of patients&#xD;
      with occluded artery.&#xD;
&#xD;
      Three groups of patients are included : patients with acute infarction, patients with acute&#xD;
      infarction requiring reperfusion treatment and patients with chronic ischemic occlusion.&#xD;
&#xD;
      Each patient would benefit from a 82Rb (82rubidium) PET/CT as part of standard management and&#xD;
      from a 68Ga-NODAGA-RGD PET/CT as part of the present study.&#xD;
&#xD;
      Patients from groups 1 and 2 will have 3 sets of both exams : one after the ischemic event,&#xD;
      one at one month and another at 3 months post event.&#xD;
&#xD;
      Patients form group 3 will have a set of both exams before reperfusion treatment and one at 2&#xD;
      months after reperfusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">December 28, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 28, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>82Rb PET/CT : assessment of change of myocardial blood flow at rest and at stress</measure>
    <time_frame>at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3</time_frame>
    <description>mL/min/g</description>
  </primary_outcome>
  <primary_outcome>
    <measure>82Rb PET/CT : assessment of change of myocardial blood flow reserve at rest and at stress</measure>
    <time_frame>at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3</time_frame>
    <description>mL/min/g</description>
  </primary_outcome>
  <primary_outcome>
    <measure>82Rb PET/CT : assessment of change of difference of myocardial blood flow at stress and at rest</measure>
    <time_frame>at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3</time_frame>
    <description>mL/min/g</description>
  </primary_outcome>
  <primary_outcome>
    <measure>68Ga-NODAGA PET/CT : assessment of change of standard uptake value (SUV)</measure>
    <time_frame>at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3</time_frame>
    <description>g/ml</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Myocardial Infarction, Acute</condition>
  <condition>Myocardial Reperfusion</condition>
  <condition>Chronic Ischemic Heart Disease</condition>
  <arm_group>
    <arm_group_label>acute infarction</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event</description>
  </arm_group>
  <arm_group>
    <arm_group_label>acute infarction requiring reperfusion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event</description>
  </arm_group>
  <arm_group>
    <arm_group_label>chronic ischemic occlusion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT before and 2 months after reperfusion treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>68Ga-NODAGA-RGD PET/CT</intervention_name>
    <description>intravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection</description>
    <arm_group_label>acute infarction</arm_group_label>
    <arm_group_label>acute infarction requiring reperfusion</arm_group_label>
    <arm_group_label>chronic ischemic occlusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>82-Rb PET/CT as part of standard care, not a comparator</intervention_name>
    <description>2 intravenous injections of standard dose of 82-Rb : the first followed by an at-rest acquisition, the second followed by a pharmacological myocardial stress acquisition</description>
    <arm_group_label>acute infarction</arm_group_label>
    <arm_group_label>acute infarction requiring reperfusion</arm_group_label>
    <arm_group_label>chronic ischemic occlusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with acute infarction or patients with acute infarction requiring reperfusion&#xD;
             treatment or patients with chronic ischemic occlusion&#xD;
&#xD;
          -  Karnofsky ≥ 80%&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy, breastfeeding&#xD;
&#xD;
          -  claustrophobia&#xD;
&#xD;
          -  contra-indication to adenosine administration&#xD;
&#xD;
          -  lack of discernment to sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John O Prior, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lausanne University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>John O Prior, PhD, MD</last_name>
    <phone>+41 21 314 43 48</phone>
    <email>john.prior@chuv.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois</name>
      <address>
        <city>Lausanne</city>
        <state>Vaud</state>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John O. Prior, MD, PhD</last_name>
      <phone>+41 (0)21-3144348</phone>
      <email>john.prior@chuv.ch</email>
    </contact>
    <investigator>
      <last_name>John O. Prior, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne Hospitals</investigator_affiliation>
    <investigator_full_name>John O. Prior</investigator_full_name>
    <investigator_title>PhD, MD, Head of Nuclear Medicine Department</investigator_title>
  </responsible_party>
  <keyword>Acute myocardial infarction</keyword>
  <keyword>Myocardial reperfusion treatment</keyword>
  <keyword>Chronic ischemic occlusion</keyword>
  <keyword>68Ga-NODAGA-RGD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_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/NCT03809689
org study id: 68Ga-NODAGA-RGD cardiac PET
nct id: NCT03809689
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is about exploring physiological angiogenesis linked to tissue repair in patients
      with acute heart infarction or chronic heart ischemia by means of 68Ga-NODAGA-RGD PET/CT
      imaging.
Several animal studies have demonstrated the expression of αvβ3 integrins on the surface of
      the endothelium present in neovessels in formation, especially during neoangiogenesis after
      myocardial ischemic injury.

      68Ga-NODAGA-RGD is a positron-emission-tomography (PET) ligand targeted towards αvβ3
      integrins. αvβ3 integrins could potentially act as a biomarker for the follow-up of heart
      infarction.

      In the present study, 68Ga-NODAGA-RGD PET/CT imaging is a tool to understand and evaluate
      tissue repair after heart lesion and its evolution allowing a better management of patients
      with occluded artery.

      Three groups of patients are included : patients with acute infarction, patients with acute
      infarction requiring reperfusion treatment and patients with chronic ischemic occlusion.

      Each patient would benefit from a 82Rb (82rubidium) PET/CT as part of standard management and
      from a 68Ga-NODAGA-RGD PET/CT as part of the present study.

      Patients from groups 1 and 2 will have 3 sets of both exams : one after the ischemic event,
      one at one month and another at 3 months post event.

      Patients form group 3 will have a set of both exams before reperfusion treatment and one at 2
      months after reperfusion.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: 82Rb PET/CT : assessment of change of myocardial blood flow at rest and at stress
time frame: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
description: mL/min/g
measure: 82Rb PET/CT : assessment of change of myocardial blood flow reserve at rest and at stress
time frame: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
description: mL/min/g
measure: 82Rb PET/CT : assessment of change of difference of myocardial blood flow at stress and at rest
time frame: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
description: mL/min/g
measure: 68Ga-NODAGA PET/CT : assessment of change of standard uptake value (SUV)
time frame: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
description: g/ml
arm group label: acute infarction
arm group type: Other
description: patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event
arm group label: acute infarction requiring reperfusion
arm group type: Other
description: patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event
arm group label: chronic ischemic occlusion
arm group type: Other
description: patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT before and 2 months after reperfusion treatment
intervention type: Other
intervention name: 68Ga-NODAGA-RGD PET/CT
description: intravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection
arm group label: acute infarction
arm group label: acute infarction requiring reperfusion
arm group label: chronic ischemic occlusion
intervention type: Diagnostic Test
intervention name: 82-Rb PET/CT as part of standard care, not a comparator
description: 2 intravenous injections of standard dose of 82-Rb : the first followed by an at-rest acquisition, the second followed by a pharmacological myocardial stress acquisition
arm group label: acute infarction
arm group label: acute infarction requiring reperfusion
arm group label: chronic ischemic occlusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: John O Prior, PhD, MD
role: Principal Investigator
affiliation: Lausanne University Hospital
last name: John O Prior, PhD, MD
phone: +41 21 314 43 48
email: john.prior@chuv.ch
facility: 
status: Recruiting
contact: 
investigator: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Lausanne Hospitals
investigator full name: John O. Prior
investigator title: PhD, MD, Head of Nuclear Medicine Department
mesh term: Myocardial Infarction
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
mesh term: Infarction
sharing ipd: No