<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/NCT03812302</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00085448</org_study_id>
    <nct_id>NCT03812302</nct_id>
  </id_info>
  <brief_title>Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)</brief_title>
  <official_title>Evaluating the Use of Gallium-68 HA-DOTATATE Positron Emission Tomography/Computerized Tomography (PET/CT) in Patients With Giant Cell Arteritis (GCA.)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <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 study is to compare the use of FDG PET/CT to Ga-68 HA-DOTATATE (abbreviated&#xD;
      DOTATATE) PET/CT in patients with active giant cell arteritis (GCA) started on prednisone to&#xD;
      understand if DOTATATE can identify more areas of active blood vessel inflammation than FDG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to prospectively evaluate the potential use of 68-Ga HA-DOTATATE&#xD;
      PET/CT for detecting medium-large vessel inflammation in a small number of GCA patients with&#xD;
      active disease, as compared to FDG PET/CT, and to understand if DOTATATE uptake correlates&#xD;
      with disease activity. Fifteen patients with active GCA (either newly-diagnosed or recently&#xD;
      relapsed disease) who are receiving glucocorticoids will be enrolled. Participants will&#xD;
      undergo baseline FDG PET/CT and baseline DOTATATE PET/CT scan. Tracer uptake will be&#xD;
      described in 8 major vascular territories. DOTATATE PET/CT will be repeated again in 6&#xD;
      months, and tracer uptake will be correlated to clinical disease activity, and medication&#xD;
      use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 9, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</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>
    <intervention_model_description>68-Ga HA-DOTATATE PET/CT will be performed in all participants as part of study protocol. Participants will receive an intravenous infusion of 3MBq/kg of 68Ga HA-DOTATATE (to max 200 MBq), followed by CT and PET imaging 60 minutes later. Tracer uptake in each vascular territory will be interpreted qualitatively and quantitatively.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of FDG vs DOTATATE vascular uptake in individual vascular territories using target-blood pool ratios (TBR)</measure>
    <time_frame>time 0 (baseline)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Qualitative comparison of FDG vs DOTATATE vascular uptake in individual vascular (scores 0-3) territories using visual uptake scores</measure>
    <time_frame>time 0 (baseline)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in vascular DOTATATE uptake scores over time (quantitatively and qualitatively)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between vascular DOTATATE uptake scores and clinical status</measure>
    <time_frame>0 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure</measure>
    <time_frame>0 and 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Giant Cell Arteritis</condition>
  <arm_group>
    <arm_group_label>DOTATATE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All 15 GCA patients will undergo 68-Ga HA-DOTATATE PET/CT imaging at baseline, in addition to FDG PET/CTA (as part of standard of care). DOTATATE PET/CT imaging will be repeated at 6 months follow-up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>68-Ga HA-DOTATATE PET/CT</intervention_name>
    <description>See arm description.</description>
    <arm_group_label>DOTATATE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants must:&#xD;
&#xD;
          1. Meet the revised GCA diagnosis criteria (modified from ref 1)&#xD;
&#xD;
          2. Have either newly-diagnosed or relapsing disease&#xD;
&#xD;
          3. Have active disease (modified from ref 1, to remove ESR/CRP requirements)&#xD;
&#xD;
          4. Have been empirically started on glucocorticoid treatment (or had baseline&#xD;
             glucocorticoid dose increased, in the case of relapsers) ≤ 2 weeks of enrolment&#xD;
&#xD;
          5. Participant must be have had (or will be willing to undergo) an urgent FDG-PET/CT as&#xD;
             part of routine clinical care.&#xD;
&#xD;
        GCA diagnosis criteria (modified from ref 1, to remove ESR requirement).&#xD;
&#xD;
          1. Age ≥ 50 years&#xD;
&#xD;
          2. And at least 1 of a. or b. :&#xD;
&#xD;
               1. Unequivocal cranial symptoms of GCA (new headache, scalp or temporal artery&#xD;
                  tenderness, ischemia-related vision loss, jaw/mouth claudication&#xD;
&#xD;
               2. Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or&#xD;
                  hip girdle pain associated with inflammatory stiffness&#xD;
&#xD;
          3. And at least 1 of a. or b.:&#xD;
&#xD;
               1. Temporal artery biopsy revealing features of GCA&#xD;
&#xD;
               2. Evidence of large-vessel vasculitis by angiography or cross-sectional imaging&#xD;
                  study such as magnetic resonance angiography (MRA), computed tomography&#xD;
                  angiography (CTA), or positron emission tomography-computed tomography (PET-CT)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not meeting the above criteria or who are unable to provide informed consent&#xD;
             will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alison Clifford</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alison Clifford</last_name>
    <phone>780-492-8789</phone>
    <email>alison5@ualberta.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jan Willem Cohen Tervaert</last_name>
    <phone>780-492-7481</phone>
    <email>cohenter@ualberta.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2G3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alison Clifford</last_name>
      <phone>780-492-8789</phone>
      <email>alison5@ualberta.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>Unizony SH, Dasgupta B, Fisheleva E, Rowell L, Schett G, Spiera R, Zwerina J, Harari O, Stone JH. Design of the tocilizumab in giant cell arteritis trial. Int J Rheumatol. 2013;2013:912562. doi: 10.1155/2013/912562. Epub 2013 Apr 7.</citation>
    <PMID>23653652</PMID>
  </results_reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>September 15, 2023</last_update_submitted>
  <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</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>Polymyalgia Rheumatica</mesh_term>
    <mesh_term>Giant Cell Arteritis</mesh_term>
    <mesh_term>Arteritis</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/NCT03812302
org study id: Pro00085448
nct id: NCT03812302
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare the use of FDG PET/CT to Ga-68 HA-DOTATATE (abbreviated
      DOTATATE) PET/CT in patients with active giant cell arteritis (GCA) started on prednisone to
      understand if DOTATATE can identify more areas of active blood vessel inflammation than FDG.
The aim of this study is to prospectively evaluate the potential use of 68-Ga HA-DOTATATE
      PET/CT for detecting medium-large vessel inflammation in a small number of GCA patients with
      active disease, as compared to FDG PET/CT, and to understand if DOTATATE uptake correlates
      with disease activity. Fifteen patients with active GCA (either newly-diagnosed or recently
      relapsed disease) who are receiving glucocorticoids will be enrolled. Participants will
      undergo baseline FDG PET/CT and baseline DOTATATE PET/CT scan. Tracer uptake will be
      described in 8 major vascular territories. DOTATATE PET/CT will be repeated again in 6
      months, and tracer uptake will be correlated to clinical disease activity, and medication
      use.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 68-Ga HA-DOTATATE PET/CT will be performed in all participants as part of study protocol. Participants will receive an intravenous infusion of 3MBq/kg of 68Ga HA-DOTATATE (to max 200 MBq), followed by CT and PET imaging 60 minutes later. Tracer uptake in each vascular territory will be interpreted qualitatively and quantitatively.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparison of FDG vs DOTATATE vascular uptake in individual vascular territories using target-blood pool ratios (TBR)
time frame: time 0 (baseline)
measure: Qualitative comparison of FDG vs DOTATATE vascular uptake in individual vascular (scores 0-3) territories using visual uptake scores
time frame: time 0 (baseline)
measure: Changes in vascular DOTATATE uptake scores over time (quantitatively and qualitatively)
time frame: 6 months
measure: Correlation between vascular DOTATATE uptake scores and clinical status
time frame: 0 and 6 months
measure: Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure
time frame: 0 and 6 months
arm group label: DOTATATE
arm group type: Experimental
description: All 15 GCA patients will undergo 68-Ga HA-DOTATATE PET/CT imaging at baseline, in addition to FDG PET/CTA (as part of standard of care). DOTATATE PET/CT imaging will be repeated at 6 months follow-up.
intervention type: Diagnostic Test
intervention name: 68-Ga HA-DOTATATE PET/CT
description: See arm description.
arm group label: DOTATATE
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Alison Clifford
role: Principal Investigator
affiliation: University of Alberta
last name: Alison Clifford
phone: 780-492-8789
email: alison5@ualberta.ca
last name: Jan Willem Cohen Tervaert
phone: 780-492-7481
email: cohenter@ualberta.ca
facility: 
status: Recruiting
contact: 
country: Canada
citation: Unizony SH, Dasgupta B, Fisheleva E, Rowell L, Schett G, Spiera R, Zwerina J, Harari O, Stone JH. Design of the tocilizumab in giant cell arteritis trial. Int J Rheumatol. 2013;2013:912562. doi: 10.1155/2013/912562. Epub 2013 Apr 7.
PMID: 23653652
responsible party type: Sponsor
mesh term: Polymyalgia Rheumatica
mesh term: Giant Cell Arteritis
mesh term: Arteritis
sharing ipd: No