<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/NCT03278275</url>
  </required_header>
  <id_info>
    <org_study_id>AK2017-1</org_study_id>
    <secondary_id>2017-002312-13</secondary_id>
    <nct_id>NCT03278275</nct_id>
  </id_info>
  <brief_title>PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105</brief_title>
  <official_title>PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105</official_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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this non-randomised, prospective study is to investigate the applicability and&#xD;
      prognostic value of uPAR PET/CT with the radioligand 68Ga-NOTA-AE105 in patients with&#xD;
      neuroendocrine tumors (NETs).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR),&#xD;
      which is a promising imaging biomarker of tumor aggressiveness. A total of 120 NET patients&#xD;
      will be subjected to a uPAR-PET/CT scan. Follow-up will be performed (from the time of the&#xD;
      angiogenesis PET/ CT) at 6 months for disease specific survival (DSS) and a 1 year follow-up&#xD;
      for PFS and OS. The uptake of 68Ga-NOTA-AE105 in tumor lesions will be quantified as&#xD;
      Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized&#xD;
      above/below median SUVmax and analyzed by Kaplan-Meier)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">July 8, 2021</completion_date>
  <primary_completion_date type="Actual">July 8, 2021</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>uPAR PET/CT imaging of patients with neuroendocrine tumors</measure>
    <time_frame>1 hour</time_frame>
    <description>The radioligand 68Ga-NOTA-AE105 can be used to visualize neuroendocrine tumors (grade G1-G3)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>uPAR PET/CT prognostic factor for progression free survival</measure>
    <time_frame>12 months</time_frame>
    <description>The uptake of the 68Ga-NOTA-AE105 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with progression free survival (PFS) neuroendocrine tumors (grade G1-G3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>uPAR PET/CT prognostic factor for overall and disease specific survival</measure>
    <time_frame>12 months</time_frame>
    <description>The uptake of the 68Ga-NOTA-AE105 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with overall and disease specific free survival (PFS) neuroendocrine tumors (grade G1-G3)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Neuroendocrine Tumors</condition>
  <arm_group>
    <arm_group_label>uPAR PET/CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One injection of the radioligand 68Ga-NOTA-AE105</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>One injection of 68Ga-NOTA-AE105</intervention_name>
    <description>One injection of 68Ga-NORA-AE105</description>
    <arm_group_label>uPAR PET/CT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PET/CT</intervention_name>
    <description>Following injection of 68Ga-NOTA-AE105 the participants will be subjected to whole body PET/CT</description>
    <arm_group_label>uPAR PET/CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with gastro-entero-pancreatic Neuroendocrine Tumors (GEP-NET; grade: G1-G3)&#xD;
             or broncho-pulmonary NET.&#xD;
&#xD;
          -  WHO performance status 0-2&#xD;
&#xD;
          -  Must be able to read and understand the patient information in Danish and to give&#xD;
             informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breast-feeding&#xD;
&#xD;
          -  Weight more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)&#xD;
&#xD;
          -  History of allergic reaction attributable to compounds of similar chemical or biologic&#xD;
             composition to 68Ga-NODAGA-E[c(RGDyK)]2&#xD;
&#xD;
          -  In case of broncho-pulmonary NET, the subtype must not be small cell lung cancer&#xD;
             (SCLC)&#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>Esben Carlsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <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>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>June 28, 2022</last_update_submitted>
  <last_update_submitted_qc>June 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Esben Carlsen</investigator_full_name>
    <investigator_title>Principle investigator, Medical doctor</investigator_title>
  </responsible_party>
  <keyword>urokinase plasminogen activator receptor</keyword>
  <keyword>uPAR PET/CT</keyword>
  <keyword>positron emission tomography</keyword>
  <keyword>neuroendocrine tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroendocrine Tumors</mesh_term>
  </condition_browse>
  <!-- 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/NCT03278275
org study id: AK2017-1
secondary id: 2017-002312-13
nct id: NCT03278275
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this non-randomised, prospective study is to investigate the applicability and
      prognostic value of uPAR PET/CT with the radioligand 68Ga-NOTA-AE105 in patients with
      neuroendocrine tumors (NETs).
68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR),
      which is a promising imaging biomarker of tumor aggressiveness. A total of 120 NET patients
      will be subjected to a uPAR-PET/CT scan. Follow-up will be performed (from the time of the
      angiogenesis PET/ CT) at 6 months for disease specific survival (DSS) and a 1 year follow-up
      for PFS and OS. The uptake of 68Ga-NOTA-AE105 in tumor lesions will be quantified as
      Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized
      above/below median SUVmax and analyzed by Kaplan-Meier)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: uPAR PET/CT imaging of patients with neuroendocrine tumors
time frame: 1 hour
description: The radioligand 68Ga-NOTA-AE105 can be used to visualize neuroendocrine tumors (grade G1-G3)
measure: uPAR PET/CT prognostic factor for progression free survival
time frame: 12 months
description: The uptake of the 68Ga-NOTA-AE105 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with progression free survival (PFS) neuroendocrine tumors (grade G1-G3)
measure: uPAR PET/CT prognostic factor for overall and disease specific survival
time frame: 12 months
description: The uptake of the 68Ga-NOTA-AE105 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with overall and disease specific free survival (PFS) neuroendocrine tumors (grade G1-G3)
arm group label: uPAR PET/CT
arm group type: Experimental
description: One injection of the radioligand 68Ga-NOTA-AE105
intervention type: Drug
intervention name: One injection of 68Ga-NOTA-AE105
description: One injection of 68Ga-NORA-AE105
arm group label: uPAR PET/CT
intervention type: Device
intervention name: PET/CT
description: Following injection of 68Ga-NOTA-AE105 the participants will be subjected to whole body PET/CT
arm group label: uPAR PET/CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Esben Carlsen, MD
role: Principal Investigator
affiliation: Rigshospitalet, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Esben Carlsen
investigator title: Principle investigator, Medical doctor
mesh term: Neuroendocrine Tumors