<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/NCT01701167</url>
  </required_header>
  <id_info>
    <org_study_id>ROMAN-01</org_study_id>
    <nct_id>NCT01701167</nct_id>
  </id_info>
  <brief_title>Verification of the Quantitative Accuracy of the PET/CT System Imaging Chain</brief_title>
  <official_title>ROMAN (PCA-9000A) PET/CT System Verification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Toshiba America Medical Systems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Toshiba America Medical Systems, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study will evaluate new technologies that have been included in the new&#xD;
      PCA-9000A PET/CT System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scope:&#xD;
&#xD;
      To evaluate the new technologies that have been included in the PCA-9000A PET/CT System, the&#xD;
      study has the following 3 goals.&#xD;
&#xD;
        -  Define and confirm all supported clinical protocols from Low-Dose CT, to PET acquisition&#xD;
           and presentation.&#xD;
&#xD;
        -  Verification of the quantitative accuracy of the imaging chain.&#xD;
&#xD;
        -  Evaluate the performance and stability of the new system and its related quality control&#xD;
           and calibration procedures.&#xD;
&#xD;
      Result (Expected):&#xD;
&#xD;
      The study is an essential step in assessing the quality of the hardware and software defining&#xD;
      the new PCA-9000A PET/CT System. Several essential parameters for the acquisition,&#xD;
      reconstruction, correction, filtering, and presentation will be estimated or adjusted during&#xD;
      this period. The evaluation will confirm PCA-9000A PET/CT System is effective for its&#xD;
      intended use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <primary_completion_date type="Anticipated">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Confirm PCA-9000A PET/CT System is Effective for Its Intended Use</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients already scheduled for a FDG test.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Patients already scheduled for an FDG test at SDMI&#xD;
&#xD;
          -  40 years and older&#xD;
&#xD;
          -  Adult must be able to sign an informed consent form&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
          -  Patients not scheduled for an FDG test at SDMI&#xD;
&#xD;
          -  39 years or younger&#xD;
&#xD;
          -  Pregnant adult female or plan to be pregnant&#xD;
&#xD;
          -  Adult who is unable to sign the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Steinberg Diagnostic Medical Imaging Centers</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Jim Kelley</last_name>
      <phone>702-240-1215</phone>
    </contact>
    <investigator>
      <last_name>Mark L Winkler, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01701167
org study id: ROMAN-01
nct id: NCT01701167
lead sponsor: 
has dmc: No
The purpose of this study will evaluate new technologies that have been included in the new
      PCA-9000A PET/CT System.
Scope:

      To evaluate the new technologies that have been included in the PCA-9000A PET/CT System, the
      study has the following 3 goals.

        -  Define and confirm all supported clinical protocols from Low-Dose CT, to PET acquisition
           and presentation.

        -  Verification of the quantitative accuracy of the imaging chain.

        -  Evaluate the performance and stability of the new system and its related quality control
           and calibration procedures.

      Result (Expected):

      The study is an essential step in assessing the quality of the hardware and software defining
      the new PCA-9000A PET/CT System. Several essential parameters for the acquisition,
      reconstruction, correction, filtering, and presentation will be estimated or adjusted during
      this period. The evaluation will confirm PCA-9000A PET/CT System is effective for its
      intended use.
observational model: Case-Only
time perspective: Cross-Sectional
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
facility: 
contact: 
investigator: 
country: United States
responsible party type: Sponsor