<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/NCT01731860</url>
  </required_header>
  <id_info>
    <org_study_id>Alpha Ring 12-001</org_study_id>
    <nct_id>NCT01731860</nct_id>
  </id_info>
  <brief_title>Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector</brief_title>
  <official_title>Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector and to Support the Pre-market Notification of a Future Product</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Imarc Research, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Philips Healthcare</source>
  <brief_summary>
    <textblock>
      A standard PET/CT scanner is comprised of two different machines: An X-ray computed&#xD;
      tomography scanner (CT), which gives information about your anatomy, and a Positron Emission&#xD;
      Tomography scanner (PET) that provides information about how the body functions. Both of&#xD;
      these work together to make the final images for doctors to review. As part of this research&#xD;
      study the investigators would like to test a new scanner technology by evaluating the quality&#xD;
      of the images obtained using this new PET system.&#xD;
&#xD;
      The scanner the investigators would use is able to do both types of examination, the standard&#xD;
      PET/CT and the additional research PET. The new PET system adds a second scanner ring to the&#xD;
      standard PET/CT. This allows the patient to stay on the same imaging table for both studies.&#xD;
      Being in this study does not change how the standard PET/CT will be done.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <primary_completion_date type="Actual">July 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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Imaging Capabilities and Performance of the Alpha Ring</measure>
    <time_frame>Within 1 month of image acquisition</time_frame>
    <description>Images acquired using the investigational device will be compared with the images obtained using the approved clinical device. The qualitative image review will be performed by the reading radiologist/nuclear medicine physician.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology.</condition>
  <arm_group>
    <arm_group_label>Patients receiving PET/CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients already scheduled for a clinically necessary PET/CT scan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Additional PET Scan</intervention_name>
    <description>Additional PET Scan with no additional radiopharmaceutical administration.</description>
    <arm_group_label>Patients receiving PET/CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients are at least 18 years&#xD;
&#xD;
          -  Patients are medically stable&#xD;
&#xD;
          -  Patients scheduled for clinically necessary PET/CT examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are pregnant&#xD;
&#xD;
          -  Patients who are unwilling/unable to sign the Informed Consent Form&#xD;
&#xD;
          -  Patients who are cognitively impaired and unable to provide informed consent&#xD;
&#xD;
          -  Patients who have experienced adverse events to PET/CT examinations&#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_official>
    <last_name>Peter F Faulhaber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Case Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>September 30, 2016</last_update_submitted>
  <last_update_submitted_qc>September 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PET/CT</keyword>
  <keyword>Philips</keyword>
  <pending_results>
    <submitted>July 7, 2017</submitted>
    <returned>August 1, 2017</returned>
    <submitted>August 21, 2017</submitted>
    <returned>September 18, 2017</returned>
    <submitted>March 9, 2020</submitted>
    <returned>March 20, 2020</returned>
    <submitted>February 7, 2022</submitted>
    <returned>March 1, 2022</returned>
  </pending_results>
  <!-- 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/NCT01731860
org study id: Alpha Ring 12-001
nct id: NCT01731860
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
A standard PET/CT scanner is comprised of two different machines: An X-ray computed
      tomography scanner (CT), which gives information about your anatomy, and a Positron Emission
      Tomography scanner (PET) that provides information about how the body functions. Both of
      these work together to make the final images for doctors to review. As part of this research
      study the investigators would like to test a new scanner technology by evaluating the quality
      of the images obtained using this new PET system.

      The scanner the investigators would use is able to do both types of examination, the standard
      PET/CT and the additional research PET. The new PET system adds a second scanner ring to the
      standard PET/CT. This allows the patient to stay on the same imaging table for both studies.
      Being in this study does not change how the standard PET/CT will be done.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Imaging Capabilities and Performance of the Alpha Ring
time frame: Within 1 month of image acquisition
description: Images acquired using the investigational device will be compared with the images obtained using the approved clinical device. The qualitative image review will be performed by the reading radiologist/nuclear medicine physician.
arm group label: Patients receiving PET/CT
arm group type: Experimental
description: Patients already scheduled for a clinically necessary PET/CT scan.
intervention type: Device
intervention name: Additional PET Scan
description: Additional PET Scan with no additional radiopharmaceutical administration.
arm group label: Patients receiving PET/CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter F Faulhaber, MD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
facility: 
country: United States
responsible party type: Sponsor
submitted: July 7, 2017
returned: August 1, 2017
submitted: August 21, 2017
returned: September 18, 2017
submitted: March 9, 2020
returned: March 20, 2020
submitted: February 7, 2022
returned: March 1, 2022