<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/NCT04438304</url>
  </required_header>
  <id_info>
    <org_study_id>CLS07</org_study_id>
    <nct_id>NCT04438304</nct_id>
  </id_info>
  <brief_title>A Diagnostic Imaging Study of 64Cu-SARTATE Using PET on Patients With Known or Suspected Neuroendocrine Tumors (DISCO)</brief_title>
  <official_title>Positron Emission Tomography Imaging of Participants With Known or Suspected Neuroendocrine Tumours Using 64Cu SARTATE: A Multi-Centre, Single Arm, Non-Randomised, Blinded-Review, Phase II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clarity Pharmaceuticals Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clarity Pharmaceuticals Ltd</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 purpose of this study is to assess the performance of imaging agent 64Cu-SARTATE in&#xD;
      participants with known or suspected Gastroenteropancreatic (GEP) Neuroendocrine Tumors&#xD;
      (NETs) as a potential new way to help diagnose NETs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 63 participants will be recruited in this study and who are confirmed or suspected to&#xD;
      have NETs based on biochemical evidence or that of conventional anatomical or molecular&#xD;
      imaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 2, 2021</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings</measure>
    <time_frame>At 4 hours post administration of 64Cu-SARTATE</time_frame>
    <description>Sensitivity and specificity on the 4-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings</measure>
    <time_frame>At 20 hours post administration of 64Cu-SARTATE</time_frame>
    <description>Sensitivity and Specificity on the 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings</measure>
    <time_frame>At 4 and 20 hours post administration of 64Cu-SARTATE</time_frame>
    <description>Lesion detection rate on composite of 4-hour and 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the proportion of concordance between 4-hour 64Cu-SARTATE to that of 68Ga-DOTATATE</measure>
    <time_frame>At 4 hours post administration of 64Cu-SARTATE</time_frame>
    <description>Concordance measured on a per-lesion basis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To compare the diagnostic performance of 64Cu-SARTATE to 68Ga-DOTATATE on a per-participant basis in participants with suspected disease only.</measure>
    <time_frame>At 4 hours and 20 hours post administration of 64Cu-SARTATE</time_frame>
    <description>Sensitivity and specificity of the 4-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.&#xD;
Sensitivity and specificity of the 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events related to 64Cu-SARTATE</measure>
    <time_frame>1 week post administration of 64Cu-SARTATE</time_frame>
    <description>Adverse events will be graded using the national cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">63</enrollment>
  <condition>Neuroendocrine Tumors</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>64Cu-SARTATE will be administered at a fixed administration dose of 200 MBq (5.4 mCi) given as a single bolus intravenous injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>64Cu-SARTATE</intervention_name>
    <description>64Cu-SARTATE will be administered at a fixed administration dose, single bolus intravenous injection, peptide mass not exceeding 60µg.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>64Cu-MeCOSar-Octreotate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent;&#xD;
&#xD;
          2. Age at enrolment ≥ 18 years;&#xD;
&#xD;
          3. Life expectancy ≥ 12 weeks;&#xD;
&#xD;
          4. Known diagnosis of GEP NET or suspicion of GEP NET based on axial imaging (e.g. on CT&#xD;
             and/or MRI and/or FDG) and/or biochemical evidence of NET;&#xD;
&#xD;
          5. Adequate recovery from acute toxic effects of any prior therapy;&#xD;
&#xD;
          6. Adequate renal function (eGFR &gt;30 ml/min);&#xD;
&#xD;
          7. Pre-study 68Ga-DOTATATE PET/CT scan performed within 5 weeks, but not closer than 6&#xD;
             hours prior to the administration of 64Cu-SARTATE;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female participant who are pregnant or lactating;&#xD;
&#xD;
          2. Male or female participant of childbearing potential not willing to practice an&#xD;
             effective method of birth control while participating on the study to avoid possible&#xD;
             damage to the foetus. Abstinence is considered acceptable;&#xD;
&#xD;
          3. Participant has received any treatment (including experimental treatment) for their&#xD;
             NET in the interval between 68Ga-DOTATATE PET/CT and 64Cu SARTATE PET/CT scan;&#xD;
&#xD;
          4. Any serious medical condition or extenuating circumstance which the investigator&#xD;
             believes may interfere with the procedures or evaluations of the study;&#xD;
&#xD;
          5. History of other active malignancy within the last 2 years the exception of adequately&#xD;
             treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin&#xD;
             cancer, in-situ carcinoma of the uterine cervix, or prostate cancer that is controlled&#xD;
             by hormone therapy (patients may continue hormone therapy while on study).&#xD;
&#xD;
          6. Active oncologic therapy within 8 weeks prior to the 68GaDOTATATE PET/CT scan&#xD;
             (long-acting somatostatin analogues are permitted and not considered active&#xD;
             oncological treatment);&#xD;
&#xD;
          7. Participants with diffuse or infiltrative hepatic involvement based on the pre-study&#xD;
             68Ga-DOTATATE PET/CT scan;&#xD;
&#xD;
          8. Participants with extensive marrow/skeletal involvement (&gt;20 lesions) based on the&#xD;
             pre-study 68Ga-DOTATATE PET/CT scan.&#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_contact>
    <last_name>Clarity Pharmaceuticals</last_name>
    <phone>+61 (0) 2 9209 4037</phone>
    <email>clinicaltrials@claritypharmaceuticals.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nepean Hospital</name>
      <address>
        <city>Kingswood</city>
        <state>New South Wales</state>
        <zip>2751</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Veronica Wong, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal North Shore Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>David Chan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Nimit Singhal, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Centre</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Grace Kong, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 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>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/NCT04438304
org study id: CLS07
nct id: NCT04438304
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the performance of imaging agent 64Cu-SARTATE in
      participants with known or suspected Gastroenteropancreatic (GEP) Neuroendocrine Tumors
      (NETs) as a potential new way to help diagnose NETs.
Up to 63 participants will be recruited in this study and who are confirmed or suspected to
      have NETs based on biochemical evidence or that of conventional anatomical or molecular
      imaging.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings
time frame: At 4 hours post administration of 64Cu-SARTATE
description: Sensitivity and specificity on the 4-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.
measure: Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings
time frame: At 20 hours post administration of 64Cu-SARTATE
description: Sensitivity and Specificity on the 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.
measure: Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings
time frame: At 4 and 20 hours post administration of 64Cu-SARTATE
description: Lesion detection rate on composite of 4-hour and 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.
measure: To assess the proportion of concordance between 4-hour 64Cu-SARTATE to that of 68Ga-DOTATATE
time frame: At 4 hours post administration of 64Cu-SARTATE
description: Concordance measured on a per-lesion basis
measure: To compare the diagnostic performance of 64Cu-SARTATE to 68Ga-DOTATATE on a per-participant basis in participants with suspected disease only.
time frame: At 4 hours and 20 hours post administration of 64Cu-SARTATE
description: Sensitivity and specificity of the 4-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.
Sensitivity and specificity of the 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.
measure: Incidence of adverse events related to 64Cu-SARTATE
time frame: 1 week post administration of 64Cu-SARTATE
description: Adverse events will be graded using the national cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
arm group label: Intervention
arm group type: Experimental
description: 64Cu-SARTATE will be administered at a fixed administration dose of 200 MBq (5.4 mCi) given as a single bolus intravenous injection.
intervention type: Drug
intervention name: 64Cu-SARTATE
description: 64Cu-SARTATE will be administered at a fixed administration dose, single bolus intravenous injection, peptide mass not exceeding 60µg.
arm group label: Intervention
other name: 64Cu-MeCOSar-Octreotate
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clarity Pharmaceuticals
phone: +61 (0) 2 9209 4037
email: clinicaltrials@claritypharmaceuticals.com
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: Australia
responsible party type: Sponsor
mesh term: Neuroendocrine Tumors