<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/NCT03755245</url>
  </required_header>
  <id_info>
    <org_study_id>T282/2018</org_study_id>
    <nct_id>NCT03755245</nct_id>
  </id_info>
  <brief_title>Biodistribution, Dosimetry and Performance of [68Ga]Ga-DOTA-Siglec-9 in Healthy and Patients With Rheumatoid Arthritis, Vasculitis or Pulmonary Sarcoidosis</brief_title>
  <acronym>SIGLEC</acronym>
  <official_title>PET/CT Study of Biodistribution and Performance of the [68Ga]Ga-DOTA-Siglec-9 in Patients With Rheumatoid Arthritis,Vasculitis or Pulmonary Sarcoidosis, and Radiation Dosimetry, Pharmacokinetics, Biodistribution, Safety and Tolerability in Healthy Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Turku University Hospital</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>
      This study evaluates safety, tolerability, biodistribution and performance of the&#xD;
      [68Ga]Ga-DOTA-Siglec-9 following a single intravenous administration in patients with active&#xD;
      rheumatoid arthritis, vasculitis or pulmonary sarcoidosis as well as radiation dosimetry,&#xD;
      plasma pharmacokinetics, biodistribution, safety and tolerability of the tracer in healthy&#xD;
      volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vascular adhesion protein 1 (VAP-1) is an inflammation inducible endothelial cell molecule&#xD;
      mediating leukocyte trafficking from blood into the sites of inflammation. Although VAP-1&#xD;
      plays important role in early phases of inflammation, its luminal expression on the&#xD;
      endothelium will remain constant if the inflammation continues, which suggest VAP-1 as a&#xD;
      promising target for molecular imaging of inflammation. We have previously shown that sialic&#xD;
      acid-binding immunoglobulin-like lectin 9 (Siglec-9) is a VAP-1 ligand, and the gallium-68&#xD;
      labeled 1,4,7,10-tetraazacyclododecane-N,N´,N´´,N´´´-tetraacetic acid conjugated peptide&#xD;
      ([68Ga]Ga-DOTA-Siglec-9) containing residues 283-297 from Siglec-9 can be used for PET&#xD;
      imaging of inflammation in various experimental models. This first-in-human study evaluates&#xD;
      safety, tolerability, biodistribution and performance of [68Ga]Ga-DOTA-Siglec-9 after single&#xD;
      intravenous injection in six healthy volunteers, and in ten patients with active rheumatoid&#xD;
      arthritis (RA), five patients with vasculitis and five patients with pulmonary sarcoidosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 23, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Whole-body distribution, plasma pharmacokinetics, radiation dosimetry, safety, tolerability and performance of [68Ga]Ga-DOTA-Siglec-9</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Whole-body distribution of [68Ga]Ga-DOTA-Siglec-9</measure>
    <time_frame>within a day</time_frame>
    <description>Knowledge how intravenously injected [68Ga]Ga-DOTA-Siglec-9 is distributed in human body</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiation dosimetry of [68Ga]Ga-DOTA-Siglec-9</measure>
    <time_frame>within a week</time_frame>
    <description>Absorbed ionisation radiation dose in critical organs due to single intravenous 140 megabecquerel injection of [68Ga]Ga-DOTA-Siglec-9</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Healthy Subjects</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Vasculitis</condition>
  <condition>Pulmonary Sarcoidosis</condition>
  <arm_group>
    <arm_group_label>[68Ga]Ga-DOTA-Siglec-9</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intravenous 140 MBq bolus injection of [68Ga]Ga-DOTA-Siglec-9 radiopharmaceutical</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>[68Ga]Ga-DOTA-Siglec-9</intervention_name>
    <description>Vascular Adhesion Protein 1 (VAP-1) targeted radiopharmaceutical</description>
    <arm_group_label>[68Ga]Ga-DOTA-Siglec-9</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy 18-70 year-old men&#xD;
&#xD;
          -  Male or female 18-70 year-old patients with active rheumatoid arthritis, vasculitis or&#xD;
             pulmonary sarcoidosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In healthy: ongoing infection/inflammation proven by blood or other tests&#xD;
&#xD;
          -  In patients with rheumatoid arthritis: no treatment with disease-modifying&#xD;
             anti-rheumatic drugs or biologic agents, and no corticosteroids for 2 weeks prior the&#xD;
             study&#xD;
&#xD;
          -  In patients with vasculitis: no immunosuppressives, and glucocorticoid less than 60 mg&#xD;
             for 2 weeks or NSAIDs for 1 day prior the study&#xD;
&#xD;
          -  In patients with pulmonary sarcoidosis: no corticosteroids for 1 week or NSAIDs for&#xD;
             day prior the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Roivainen, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Turku University Hospital, Turku PET Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Turku University Hospital, Turku PET Centre</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>October 19, 2022</last_update_submitted>
  <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Turku University Hospital</investigator_affiliation>
    <investigator_full_name>Anne Roivainen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Sarcoidosis, Pulmonary</mesh_term>
    <mesh_term>Vasculitis</mesh_term>
    <mesh_term>Sarcoidosis</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/NCT03755245
org study id: T282/2018
nct id: NCT03755245
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates safety, tolerability, biodistribution and performance of the
      [68Ga]Ga-DOTA-Siglec-9 following a single intravenous administration in patients with active
      rheumatoid arthritis, vasculitis or pulmonary sarcoidosis as well as radiation dosimetry,
      plasma pharmacokinetics, biodistribution, safety and tolerability of the tracer in healthy
      volunteers.
Vascular adhesion protein 1 (VAP-1) is an inflammation inducible endothelial cell molecule
      mediating leukocyte trafficking from blood into the sites of inflammation. Although VAP-1
      plays important role in early phases of inflammation, its luminal expression on the
      endothelium will remain constant if the inflammation continues, which suggest VAP-1 as a
      promising target for molecular imaging of inflammation. We have previously shown that sialic
      acid-binding immunoglobulin-like lectin 9 (Siglec-9) is a VAP-1 ligand, and the gallium-68
      labeled 1,4,7,10-tetraazacyclododecane-N,N´,N´´,N´´´-tetraacetic acid conjugated peptide
      ([68Ga]Ga-DOTA-Siglec-9) containing residues 283-297 from Siglec-9 can be used for PET
      imaging of inflammation in various experimental models. This first-in-human study evaluates
      safety, tolerability, biodistribution and performance of [68Ga]Ga-DOTA-Siglec-9 after single
      intravenous injection in six healthy volunteers, and in ten patients with active rheumatoid
      arthritis (RA), five patients with vasculitis and five patients with pulmonary sarcoidosis.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Whole-body distribution, plasma pharmacokinetics, radiation dosimetry, safety, tolerability and performance of [68Ga]Ga-DOTA-Siglec-9
primary purpose: Other
masking: None (Open Label)
measure: Whole-body distribution of [68Ga]Ga-DOTA-Siglec-9
time frame: within a day
description: Knowledge how intravenously injected [68Ga]Ga-DOTA-Siglec-9 is distributed in human body
measure: Radiation dosimetry of [68Ga]Ga-DOTA-Siglec-9
time frame: within a week
description: Absorbed ionisation radiation dose in critical organs due to single intravenous 140 megabecquerel injection of [68Ga]Ga-DOTA-Siglec-9
arm group label: [68Ga]Ga-DOTA-Siglec-9
arm group type: Other
description: Intravenous 140 MBq bolus injection of [68Ga]Ga-DOTA-Siglec-9 radiopharmaceutical
intervention type: Other
intervention name: [68Ga]Ga-DOTA-Siglec-9
description: Vascular Adhesion Protein 1 (VAP-1) targeted radiopharmaceutical
arm group label: [68Ga]Ga-DOTA-Siglec-9
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anne Roivainen, Professor
role: Principal Investigator
affiliation: Turku University Hospital, Turku PET Centre
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Turku University Hospital
investigator full name: Anne Roivainen
investigator title: Professor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Sarcoidosis, Pulmonary
mesh term: Vasculitis
mesh term: Sarcoidosis