<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/NCT02258165</url>
  </required_header>
  <id_info>
    <org_study_id>IMAGE</org_study_id>
    <nct_id>NCT02258165</nct_id>
  </id_info>
  <brief_title>Impact of Gated PET/CT in the Diagnosis of Advanced Ovarian Cancer</brief_title>
  <acronym>IMAGE</acronym>
  <official_title>Impact of Gated PET/CT on the Diagnosis of Distant Metastases of Advanced Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queensland Centre for Gynaecological Cancer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of Queensland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal Brisbane and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queensland Centre for Gynaecological Cancer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be the first prospective study enrolling consecutive patients with advanced&#xD;
      ovarian cancer to determine the prevalence of thoracic and extra-abdominal involvement in&#xD;
      this patient group and the relative value of gated PET and CT for diagnosing extra-abdominal&#xD;
      involvement. This study will also answer a number of other stil unanswered questions: the&#xD;
      impact of gating and the impact of gated PET on clinical management of patients with advanced&#xD;
      ovarian cancer. This study also individualises patients' treatment to allow patients who may&#xD;
      benefit most form optimal surgical cytoreduction and those who are better treated by&#xD;
      neoadjuvant&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study directly compares standard CT scanning with PET/CT scanning with gating (computer&#xD;
      adjusted for breathing excursions) in patients with advanced EOC. The primary objective of&#xD;
      this study is to obtain definitive evidence on the value of gated PET/CT compared to current&#xD;
      standard imaging (CT scan) for the diagnosis of extra-abdominal and thoracic involvement.&#xD;
      This study will give precise estimates on the sensitivity and specificity of CT compared with&#xD;
      gated PET/CT, and allow calculation of the positive predictive value and negative predictive&#xD;
      value. The proportion of patients upstaged to Stage IV (extra-abdominal involvement) from&#xD;
      Stage III by gated PET/CT will be calculated.&#xD;
&#xD;
      Secondary objectives are to establish:&#xD;
&#xD;
        -  The impact of gated PET/CT images on clinical management (changes to planned treatment;&#xD;
           detection of metastatic spread to &quot;unexpected&quot; sites).&#xD;
&#xD;
        -  The validity of gated PET/CT positive (FDG avid) findings through histological&#xD;
           evaluation.&#xD;
&#xD;
        -  We will also receive information of &quot;unusual&quot; (unexpected) FDG positive metastatic&#xD;
           lesions that would normally not noticed on CT scans.&#xD;
&#xD;
      Current standard treatment for patients with advanced EOC is upfront surgery as long as all&#xD;
      tumour is confined to the pelvis and the abdomen. Unfortunately, EOC is often found at&#xD;
      distant sites where it was not suspected during surgery (which is too late). If the surgeon&#xD;
      had had prior knowledge of this disease distribution, the surgeon would not have subjected&#xD;
      the patient to a long and invasive surgical procedure. Instead they but would have referred&#xD;
      the patient to upfront chemotherapy, which is widely accepted clinical practice throughout&#xD;
      Australia.&#xD;
&#xD;
      This study aims to increase the diagnostic accuracy of preoperative medical imaging and&#xD;
      subject a larger group of patients with advanced EOC to accurate management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Actual">December 2022</completion_date>
  <primary_completion_date type="Actual">October 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients upstaged from Stage IV from Stage III by gated PET/CT</measure>
    <time_frame>one to six months</time_frame>
    <description>The primary hypothesis is that the true prevalence of extra-abdominal involvement diagnosed by gated PET/CT will be higher than the prevalence deteted by CT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of gated PET/CT images on clinical management</measure>
    <time_frame>one to six months</time_frame>
    <description>Changes to planned treatment for ovarian cancer based on the detection of metastatic spead to &quot;unexpected sites&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The validity of gated PET/CT positive (FDG avid) findings through histological evaluation</measure>
    <time_frame>one to six months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">84</enrollment>
  <condition>Ovarian Cancer Stage III</condition>
  <condition>Ovarian Cancer Stage IV</condition>
  <arm_group>
    <arm_group_label>Advanced ovarian cancer</arm_group_label>
    <description>gated PET/CT imaging</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PET/CT</intervention_name>
    <description>PET/CT (without respiratory gating) is performed on an ad-hoc basis in patients with advanced ovarian cancer in the lead up to surgery. The sensitivity of PET/CT for detecting low volume pleural disease is likely reduced by respiratory motion during the ten minute acquisition time over the chest. By &quot;freezing&quot; this respiratory motion with respiratory gating, we hope that gated PET/CT detection of pleural metastases will improve over non-gated PET images.</description>
    <arm_group_label>Advanced ovarian cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women with advanced ovarian cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female ≥18 years of age&#xD;
&#xD;
          -  Suspected or histologically/cytologically proven Stage III or IV epithelial ovarian,&#xD;
             fallopian tube, and primary peritoneal cancer&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤3&#xD;
&#xD;
          -  Negative serum or urine pregnancy test in pre-menopausal women and women &lt; 2 years&#xD;
             after the onset of menopause&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Estimated life expectancy of &lt;6 months&#xD;
&#xD;
          -  Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer&#xD;
&#xD;
          -  Laparotomy performed as component of staging/clinical management prior to gated PET/CT&#xD;
             being performed.&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Obermair</last_name>
    <role>Study Chair</role>
    <affiliation>Queensland Centre for Gynaecological Cancer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Brisbane and Women's Hospital</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mater Health Services</name>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ovarian cancer</keyword>
  <keyword>imaging</keyword>
  <keyword>gated PET/CT scan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</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/NCT02258165
org study id: IMAGE
nct id: NCT02258165
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study will be the first prospective study enrolling consecutive patients with advanced
      ovarian cancer to determine the prevalence of thoracic and extra-abdominal involvement in
      this patient group and the relative value of gated PET and CT for diagnosing extra-abdominal
      involvement. This study will also answer a number of other stil unanswered questions: the
      impact of gating and the impact of gated PET on clinical management of patients with advanced
      ovarian cancer. This study also individualises patients' treatment to allow patients who may
      benefit most form optimal surgical cytoreduction and those who are better treated by
      neoadjuvant
This study directly compares standard CT scanning with PET/CT scanning with gating (computer
      adjusted for breathing excursions) in patients with advanced EOC. The primary objective of
      this study is to obtain definitive evidence on the value of gated PET/CT compared to current
      standard imaging (CT scan) for the diagnosis of extra-abdominal and thoracic involvement.
      This study will give precise estimates on the sensitivity and specificity of CT compared with
      gated PET/CT, and allow calculation of the positive predictive value and negative predictive
      value. The proportion of patients upstaged to Stage IV (extra-abdominal involvement) from
      Stage III by gated PET/CT will be calculated.

      Secondary objectives are to establish:

        -  The impact of gated PET/CT images on clinical management (changes to planned treatment;
           detection of metastatic spread to "unexpected" sites).

        -  The validity of gated PET/CT positive (FDG avid) findings through histological
           evaluation.

        -  We will also receive information of "unusual" (unexpected) FDG positive metastatic
           lesions that would normally not noticed on CT scans.

      Current standard treatment for patients with advanced EOC is upfront surgery as long as all
      tumour is confined to the pelvis and the abdomen. Unfortunately, EOC is often found at
      distant sites where it was not suspected during surgery (which is too late). If the surgeon
      had had prior knowledge of this disease distribution, the surgeon would not have subjected
      the patient to a long and invasive surgical procedure. Instead they but would have referred
      the patient to upfront chemotherapy, which is widely accepted clinical practice throughout
      Australia.

      This study aims to increase the diagnostic accuracy of preoperative medical imaging and
      subject a larger group of patients with advanced EOC to accurate management.
observational model: Cohort
time perspective: Prospective
measure: Proportion of patients upstaged from Stage IV from Stage III by gated PET/CT
time frame: one to six months
description: The primary hypothesis is that the true prevalence of extra-abdominal involvement diagnosed by gated PET/CT will be higher than the prevalence deteted by CT.
measure: Impact of gated PET/CT images on clinical management
time frame: one to six months
description: Changes to planned treatment for ovarian cancer based on the detection of metastatic spead to "unexpected sites"
measure: The validity of gated PET/CT positive (FDG avid) findings through histological evaluation
time frame: one to six months
arm group label: Advanced ovarian cancer
description: gated PET/CT imaging
intervention type: Device
intervention name: PET/CT
description: PET/CT (without respiratory gating) is performed on an ad-hoc basis in patients with advanced ovarian cancer in the lead up to surgery. The sensitivity of PET/CT for detecting low volume pleural disease is likely reduced by respiratory motion during the ten minute acquisition time over the chest. By "freezing" this respiratory motion with respiratory gating, we hope that gated PET/CT detection of pleural metastases will improve over non-gated PET images.
arm group label: Advanced ovarian cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas Obermair
role: Study Chair
affiliation: Queensland Centre for Gynaecological Cancer
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: No