<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/NCT03229772</url>
  </required_header>
  <id_info>
    <org_study_id>117.02-2015-GES-0002</org_study_id>
    <nct_id>NCT03229772</nct_id>
  </id_info>
  <brief_title>Demonstration of the &quot;SPECT/CT System With CZT Detectors&quot; Imaging Performance in a Clinical Setting</brief_title>
  <official_title>Demonstration of the &quot;SPECT/CT System With CZT Detectors&quot; Imaging Performance in a Clinical Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GE Healthcare</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of the study is to obtain sample clinical images that are evaluated by&#xD;
      physicians in support of regulatory submissions. Additionally, the study will provide data&#xD;
      for current and future product development and it will provide clinical images and data for&#xD;
      marketing use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic Image Quality</measure>
    <time_frame>12 weeks</time_frame>
    <description>Diagnostic Image Quality will be rated by 2 radiologist using a 5 point Likert Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Image Resolution</measure>
    <time_frame>12 weeks</time_frame>
    <description>Image Resolution will be rated by 2 radiologist using a 5 point Likert Scale</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Subjects indicated for dynamic nuclear medicine scanning</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The trial will consist of a single arm composed of subjects with preexisting indications for dynamic nuclear medicine scanning at the site. All patients will undergo nuclear medicine scintigraphy using the GE Discovery 670 NM/CT device with and without CZT enabled during a single visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Discovery NM/CT 670 CZT Imaging Scan</intervention_name>
    <description>At a single visit, subjects will undergo nuclear medicine scintigraphy imaging scanning on the investigational GE Discovery 670 NM/CT CZT (with CZT) device and the commercial GE Discovery 670c (without CZT).</description>
    <arm_group_label>Subjects indicated for dynamic nuclear medicine scanning</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. are 18-years old and older;&#xD;
&#xD;
          2. is able to sign and date the informed consent form; AND&#xD;
&#xD;
          3. have been prescribed by a physician a nuclear medicine exam that is within the&#xD;
             intended use of the device.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who were referred for dynamic nuclear medicine scan because of the need to be&#xD;
             injected twice (once for the conventional acquisition and once for the investigational&#xD;
             device) that would result in an increase dose burden on patient.&#xD;
&#xD;
          2. Pregnant or lactating women&#xD;
&#xD;
          3. Who were previously enrolled in this study;&#xD;
&#xD;
          4. Who have contraindication for the radiopharmaceutical&#xD;
&#xD;
          5. Who have any conditions that, in the opinion of the Investigator, would interfere with&#xD;
             the evaluation of the results or constitute a health hazard for the subject;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zohar Keidar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam Health Care Center</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>May 11, 2016</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03229772
org study id: 117.02-2015-GES-0002
nct id: NCT03229772
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The primary purpose of the study is to obtain sample clinical images that are evaluated by
      physicians in support of regulatory submissions. Additionally, the study will provide data
      for current and future product development and it will provide clinical images and data for
      marketing use.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Diagnostic Image Quality
time frame: 12 weeks
description: Diagnostic Image Quality will be rated by 2 radiologist using a 5 point Likert Scale
measure: Image Resolution
time frame: 12 weeks
description: Image Resolution will be rated by 2 radiologist using a 5 point Likert Scale
arm group label: Subjects indicated for dynamic nuclear medicine scanning
arm group type: Other
description: The trial will consist of a single arm composed of subjects with preexisting indications for dynamic nuclear medicine scanning at the site. All patients will undergo nuclear medicine scintigraphy using the GE Discovery 670 NM/CT device with and without CZT enabled during a single visit.
intervention type: Device
intervention name: Discovery NM/CT 670 CZT Imaging Scan
description: At a single visit, subjects will undergo nuclear medicine scintigraphy imaging scanning on the investigational GE Discovery 670 NM/CT CZT (with CZT) device and the commercial GE Discovery 670c (without CZT).
arm group label: Subjects indicated for dynamic nuclear medicine scanning
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Zohar Keidar, MD
role: Principal Investigator
affiliation: Rambam Health Care Center
facility: 
country: Israel
responsible party type: Sponsor
sharing ipd: No