<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/NCT02970786</url>
  </required_header>
  <id_info>
    <org_study_id>AK-2015-1</org_study_id>
    <nct_id>NCT02970786</nct_id>
  </id_info>
  <brief_title>Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2&#xD;
      for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a&#xD;
      high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can&#xD;
      potentially be used in early response assessment to anti-angiogenic treatment.&#xD;
&#xD;
      This is a first-in-man study to test the radio tracer in cancer patients. Safety,&#xD;
      biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour&#xD;
      and 2 hours post injection).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2&#xD;
      for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a&#xD;
      high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can&#xD;
      potentially be used in early response assessment to anti-angiogenic treatment.&#xD;
&#xD;
      This is a first-in-man study to test the radio tracer in cancer patients. Safety,&#xD;
      biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour&#xD;
      and 2 hours post injection).&#xD;
&#xD;
      The primary end points are safety, biodistribution and dosimetry of 68Ga-NODAGA-E[c(RGDyK)]2.&#xD;
      In addition, the quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 will be compared to the&#xD;
      expression of integrin αvβ3 measured directly in tumor tissue obtained by surgery or&#xD;
      biopsies. The study will be monitored and evaluated in accordance with the principles of Good&#xD;
      Clinical Practice (GCP).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biodistribution</measure>
    <time_frame>2 hours</time_frame>
    <description>Change in biodistribution estimated by PET</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dosimetry</measure>
    <time_frame>2 hours</time_frame>
    <description>Dosimetry will be calculated with the use of OLINDA/EXM software (mSv) based on repeated PET imaging with the radiotracer 68Ga-NODAGA-E(c[RGDyK])2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety of 68Ga-NODAGA-E(c[RGDyK])2 PET as measured by the number of participants with adverse events and significant changes in vital signs, electrocardiogram, and laboratory data.</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantitative uptake of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2 in tumor tissue</measure>
    <time_frame>2 hours</time_frame>
    <description>The patients will be PET scanned 10 minutes, 1 hour and 2 hours post injection of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2. These timepoints will be used for assessment of tumor uptake by the use of maximum and mean standardized uptake value (SUV).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Neuroendocrine Carcinoma</condition>
  <condition>Breast Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>68Ga-NODAGA-E(c[RGDyK])2 PET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One injection of 68Ga-NODAGA-E(c[RGDyK])2 PET (app. 200 MBq) followed by 3 PET/CT scans 10 minutes, 1 hour and 2 hours post injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Injection of 68Ga-NODAGA-E(c[RGDyK])2</intervention_name>
    <description>Following one injection of 68Ga-NODAGA-E(c[RGDyK])2 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection</description>
    <arm_group_label>68Ga-NODAGA-E(c[RGDyK])2 PET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with neuroendocrine cancer, breast cancer or ovarian cancer&#xD;
&#xD;
          -  Capable of understanding and giving full informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Lactation&#xD;
&#xD;
          -  Obesity (weight above 140 kg)&#xD;
&#xD;
          -  Claustrophobia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Malene M Clausen, MD, PhD</last_name>
    <phone>+4522524536</phone>
    <email>malene.martini.clausen@regionh.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andreas Kjaer, Professor</last_name>
    <phone>+4535454011</phone>
    <email>andreas.kjaer@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>November 18, 2016</last_update_submitted>
  <last_update_submitted_qc>November 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Malene Martini Clausen</investigator_full_name>
    <investigator_title>Principal Investigator, MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Neuroendocrine</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/NCT02970786
org study id: AK-2015-1
nct id: NCT02970786
lead sponsor: 
has dmc: No
The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2
      for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a
      high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can
      potentially be used in early response assessment to anti-angiogenic treatment.

      This is a first-in-man study to test the radio tracer in cancer patients. Safety,
      biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour
      and 2 hours post injection).
The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2
      for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a
      high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can
      potentially be used in early response assessment to anti-angiogenic treatment.

      This is a first-in-man study to test the radio tracer in cancer patients. Safety,
      biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour
      and 2 hours post injection).

      The primary end points are safety, biodistribution and dosimetry of 68Ga-NODAGA-E[c(RGDyK)]2.
      In addition, the quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 will be compared to the
      expression of integrin αvβ3 measured directly in tumor tissue obtained by surgery or
      biopsies. The study will be monitored and evaluated in accordance with the principles of Good
      Clinical Practice (GCP).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Biodistribution
time frame: 2 hours
description: Change in biodistribution estimated by PET
measure: Dosimetry
time frame: 2 hours
description: Dosimetry will be calculated with the use of OLINDA/EXM software (mSv) based on repeated PET imaging with the radiotracer 68Ga-NODAGA-E(c[RGDyK])2.
measure: Safety of 68Ga-NODAGA-E(c[RGDyK])2 PET as measured by the number of participants with adverse events and significant changes in vital signs, electrocardiogram, and laboratory data.
time frame: 48 hours
measure: Quantitative uptake of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2 in tumor tissue
time frame: 2 hours
description: The patients will be PET scanned 10 minutes, 1 hour and 2 hours post injection of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2. These timepoints will be used for assessment of tumor uptake by the use of maximum and mean standardized uptake value (SUV).
arm group label: 68Ga-NODAGA-E(c[RGDyK])2 PET
arm group type: Experimental
description: One injection of 68Ga-NODAGA-E(c[RGDyK])2 PET (app. 200 MBq) followed by 3 PET/CT scans 10 minutes, 1 hour and 2 hours post injection
intervention type: Drug
intervention name: Injection of 68Ga-NODAGA-E(c[RGDyK])2
description: Following one injection of 68Ga-NODAGA-E(c[RGDyK])2 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection
arm group label: 68Ga-NODAGA-E(c[RGDyK])2 PET
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Malene M Clausen, MD, PhD
phone: +4522524536
email: malene.martini.clausen@regionh.dk
last name: Andreas Kjaer, Professor
phone: +4535454011
email: andreas.kjaer@regionh.dk
facility: 
status: Recruiting
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Malene Martini Clausen
investigator title: Principal Investigator, MD, PhD
mesh term: Carcinoma, Neuroendocrine
sharing ipd: No