<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/NCT04440956</url>
  </required_header>
  <id_info>
    <org_study_id>CL01</org_study_id>
    <nct_id>NCT04440956</nct_id>
  </id_info>
  <brief_title>An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours</brief_title>
  <official_title>Positron Emission Tomography (PET) Imaging of Patients With Low &amp; Intermediate Grade Neuroendocrine Tumors Using 64Cu-SARTATE: A Single Centre, Open-Label, Non-Randomized, Phase-0 Microdosing Investigation</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to examine the safety and potential effectiveness of a&#xD;
      drug molecule called 64Cu-SARTATE as a potential new way to detect neuroendocrine cancers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 21, 2015</start_date>
  <completion_date type="Actual">February 25, 2016</completion_date>
  <primary_completion_date type="Actual">February 25, 2016</primary_completion_date>
  <phase>Early 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>Incidence of adverse events related to 64Cu-SARTATE</measure>
    <time_frame>1 week post administration</time_frame>
    <description>Occurrence of adverse clinical, biochemical or haematological events assessed for up to 1 week post administration of 64Cu-SARTATE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of injected 64Cu-SARTATE dose found in organs of interest</measure>
    <time_frame>At 30 minutes following administration</time_frame>
    <description>Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of injected 64Cu-SARTATE dose found in organs of interest</measure>
    <time_frame>At 1 hour following administration</time_frame>
    <description>Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of injected 64Cu-SARTATE dose found in organs of interest</measure>
    <time_frame>At 4 hours following administration</time_frame>
    <description>Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of injected 64Cu-SARTATE dose found in organs of interest</measure>
    <time_frame>At 24 hours following administration</time_frame>
    <description>Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absorbed organ dose</measure>
    <time_frame>At 30 minutes following administration</time_frame>
    <description>Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absorbed organ dose</measure>
    <time_frame>At 1 hour following administration</time_frame>
    <description>Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absorbed organ dose</measure>
    <time_frame>At 4 hours following administration</time_frame>
    <description>Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absorbed organ dose</measure>
    <time_frame>At 24 hours following administration</time_frame>
    <description>Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demonstration of known malignancy</measure>
    <time_frame>30 minutes, 1 hour, 4 hours and 24 hours following administration</time_frame>
    <description>Whether 64Cu-SARTATE PET/CT scans demonstrate known sites of 68Ga-DOTATATE avid malignancy with equivalent or greater tumor to background ratios, where background uptake is that found in a non-tumor containing area of interest as decided upon by the nuclear medicine physician at the time of scan assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uptake in non-physiological, non-tumor containing tissues</measure>
    <time_frame>30 minutes, 1 hour, 4 hours and 24 hours following administration</time_frame>
    <description>Whether 64Cu-SARTATE PET/CT scans demonstrate any non-physiological, non-tumor containing tissues with uptake greater than 1.5 x that of the background, where background uptake is defined as in secondary endpoint.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Neuroendocrine Tumors</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200MBq of 64Cu-MeCOSar-Octreotate (&quot;64Cu-SARTATE&quot;) given as a single bolus intravenous injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>64Cu-SARTATE</intervention_name>
    <description>200MBq of 64Cu-MeCOSar-Octreotate (&quot;64Cu-SARTATE&quot;) given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms.</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 greater than or equal to 18 years&#xD;
&#xD;
          3. Life expectancy greater than or equal to 8 weeks&#xD;
&#xD;
          4. Low and Intermediate Grade (Ki-67 index &lt;20%) neuroendocrine tumors (NET)&#xD;
&#xD;
          5. At least one site of active somatostatin receptor positive malignancy, as demonstrated&#xD;
             on the pre-study 68Ga-DOTATATE PET/CT scan performed as part of routine clinical care&#xD;
&#xD;
          6. Subjects with an estimated glomerular filtration rate (eGFR) greater than 60ml/min as&#xD;
             measured using the MDRD formula (Modification of Diet in Renal Disease).&#xD;
&#xD;
          7. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or breastfeeding females&#xD;
&#xD;
          2. Known sensitivity or allergy to somatostatin analogues&#xD;
&#xD;
          3. Subjects who have received interventional treatment for their NET in the interval&#xD;
             between 68Ga-DOTATATE PET/CT &amp; 64Cu-SARTATE PET/CT scan&#xD;
&#xD;
          4. Treatment with long acting somatostatin analogues within 28 days prior to the&#xD;
             administration of Investigational Product&#xD;
&#xD;
          5. Treatment with short acting somatostatin analogues within 24hrs prior to the&#xD;
             administration of Investigational Product&#xD;
&#xD;
          6. QTc interval greater than 0.44seconds as measured by screening ECG&#xD;
&#xD;
          7. Any serious medical condition which the investigator feels may interfere with the&#xD;
             procedures or evaluations of the study&#xD;
&#xD;
          8. Patients unwilling or unable to comply with protocol or with a history of&#xD;
             non-compliance or inability to grant informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</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>
  <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/NCT04440956
org study id: CL01
nct id: NCT04440956
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary purpose of this study is to examine the safety and potential effectiveness of a
      drug molecule called 64Cu-SARTATE as a potential new way to detect neuroendocrine cancers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Incidence of adverse events related to 64Cu-SARTATE
time frame: 1 week post administration
description: Occurrence of adverse clinical, biochemical or haematological events assessed for up to 1 week post administration of 64Cu-SARTATE.
measure: Percentage of injected 64Cu-SARTATE dose found in organs of interest
time frame: At 30 minutes following administration
description: Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
measure: Percentage of injected 64Cu-SARTATE dose found in organs of interest
time frame: At 1 hour following administration
description: Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
measure: Percentage of injected 64Cu-SARTATE dose found in organs of interest
time frame: At 4 hours following administration
description: Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
measure: Percentage of injected 64Cu-SARTATE dose found in organs of interest
time frame: At 24 hours following administration
description: Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
measure: Absorbed organ dose
time frame: At 30 minutes following administration
description: Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)
measure: Absorbed organ dose
time frame: At 1 hour following administration
description: Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)
measure: Absorbed organ dose
time frame: At 4 hours following administration
description: Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)
measure: Absorbed organ dose
time frame: At 24 hours following administration
description: Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)
measure: Demonstration of known malignancy
time frame: 30 minutes, 1 hour, 4 hours and 24 hours following administration
description: Whether 64Cu-SARTATE PET/CT scans demonstrate known sites of 68Ga-DOTATATE avid malignancy with equivalent or greater tumor to background ratios, where background uptake is that found in a non-tumor containing area of interest as decided upon by the nuclear medicine physician at the time of scan assessment.
measure: Uptake in non-physiological, non-tumor containing tissues
time frame: 30 minutes, 1 hour, 4 hours and 24 hours following administration
description: Whether 64Cu-SARTATE PET/CT scans demonstrate any non-physiological, non-tumor containing tissues with uptake greater than 1.5 x that of the background, where background uptake is defined as in secondary endpoint.
arm group label: Intervention
arm group type: Experimental
description: 200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection.
intervention type: Drug
intervention name: 64Cu-SARTATE
description: 200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms.
arm group label: Intervention
other name: 64Cu-MeCOSar-Octreotate
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Neuroendocrine Tumors
sharing ipd: No