<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/NCT03272997</url>
  </required_header>
  <id_info>
    <org_study_id>PET-CT in UPE</org_study_id>
    <nct_id>NCT03272997</nct_id>
  </id_info>
  <brief_title>The Value of PET-CT in Pleural Effusions</brief_title>
  <official_title>The Diagnostic Power of 18F-FDG PET-CT Scanning for Discriminating Malignant From Non-malignant Causes in Unilateral Pleural Effusions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Naestved Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Naestved Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim is to asses the diagnostic power of 18F-FDG PET-CT in discriminating&#xD;
      malignant from nonmalignant causes in patients with a recurrent unilateral pleural effusion&#xD;
      of unknown origin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators follow the STARD 2015 guideline for reporting diagnostic accuracy studies.&#xD;
&#xD;
      The investigators will review the hospital's administrative database of patients who&#xD;
      underwent a thoracocentesis from January 2013 to January 2015. Patients at Department of&#xD;
      Respiratory Medicine, Zealand University Hospital, Roskilde and Department of Respiratory&#xD;
      Medicine, Naestved Hospital, Region Zealand, Denmark (two large respiratory centres with&#xD;
      specialised functions) is eligible for inclusion. Patients are included irrespective of&#xD;
      cytology and chemical analysis.&#xD;
&#xD;
      The investigators will review the patients' medical records and images retrospectively. To&#xD;
      reduce the number of false negatives, the investigators complete a 1-year follow-up.&#xD;
&#xD;
      Patients older than 16 years are included, irrespective of smoking history and comorbidities,&#xD;
      if both thoracocenteses, chest x-ray, a CT-scanning and a PET-CT scanning is performed.&#xD;
      Exclusion criteria are previously diagnosed lung cancer, thoracic malignancy or incomplete&#xD;
      data.&#xD;
&#xD;
      Classification of results The investigators chose the combination of investigations&#xD;
      recommended by the internationally acknowledged BTS guideline, which is endorsed by the&#xD;
      Danish Society of Respiratory Medicine. Thoracocentesis, chest x-ray, CT findings and PET-CT&#xD;
      findings is categorized as either normal (i.e. not suggestive of any aetiology of the&#xD;
      unilateral pleural effusion), suggestive of other lung pathology or suggestive of malignancy&#xD;
      (i.e. representing a possible aetiology of the unilateral pleural effusion).&#xD;
&#xD;
      The thoracocentesis is classified as malignant if cytological examination revealed malignant&#xD;
      cells. The chest x-ray is classified as malignant if suspicion of malignant disease is not&#xD;
      rejected. The CT findings are classified as malignant according to Leung et. al. for pleural&#xD;
      abnormalities (circumferential pleural thickening, nodular pleural thickening, parietal&#xD;
      pleural thickening &gt; 1 cm and mediastinal pleural involvement) and The Fleischner Society for&#xD;
      parenchymal abnormalities (nodules &gt; 8 mm). The PET-CT findings are classified as malignant&#xD;
      if any findings suspicious for malignancy.&#xD;
&#xD;
      CT and PET-CT images, as well as the scan reports by the radiologist and the nuclear medicine&#xD;
      physician, is reviewed by two experienced pulmonologists. They are blinded to all patient&#xD;
      information, including final diagnosis.&#xD;
&#xD;
      The final diagnosis, the reference standard, is extracted from the patients' medical records.&#xD;
      When no diagnosis is found, two investigators agree on a consensus diagnosis based on all&#xD;
      investigation results. If no reasonable diagnosis can be established based on the findings,&#xD;
      the patient case is categorized as having no final diagnosis. These cases are treated as a&#xD;
      worst-case scenario, i.e. patients with a malignant disease are treated as false negative,&#xD;
      and patients without malignant disease are treated as false positive.&#xD;
&#xD;
      Statistics Data are presented as frequencies and/or mean ± standard deviation (SD). Test&#xD;
      characteristics were compared using McNemar's test with Bonferroni correction (two-sided&#xD;
      level of significance &lt; o.o5). Diagnostic power of thoracocentesis, chest x-ray, CT-scanning,&#xD;
      PET-CT scanning and the combination are calculated. Diagnostic power is defined as true&#xD;
      positive, true negative, false positive, false negative, sensitivity, specificity, likelihood&#xD;
      ratio+, likelihood ratio-, positive predictive value (PPV), negative predictive value (NPV)&#xD;
      and diagnostic accuracy (TP+TN)/(TP+FP+TN+FN).&#xD;
&#xD;
      The combined sensitivity will be calculated using the formula:&#xD;
&#xD;
      Sensitivitytest A + Sensitivitytest B + Sensitivitytest … - (Sensitivitytest A x&#xD;
      Sensitivitytest B x Sensitivitytest …)&#xD;
&#xD;
      The combined specificity will be calculated using the formula:&#xD;
&#xD;
      Specificitytest A x Specificitytest B x Specificitytest… Data were analyzed using STATA&#xD;
      (StataCorp LLC, Version 15.0, College Station, Texas, USA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity PET-CT</measure>
    <time_frame>1 year</time_frame>
    <description>TP / (TP + FN)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CT-Specificity</measure>
    <time_frame>1 year</time_frame>
    <description>TN / (TN+FP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PET-CT-Specificity</measure>
    <time_frame>1 year</time_frame>
    <description>TN / (TN+FP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CT-Sensitivity</measure>
    <time_frame>1 year</time_frame>
    <description>TP / (TP + FN)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the diagnostic power</measure>
    <time_frame>1 year</time_frame>
    <description>McNemars' test with Bonferroni</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CT-Likelihood ratio+</measure>
    <time_frame>1 Year</time_frame>
    <description>LR+ = sensitivity / (1-specificity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PET-CT-Likelihood ratio+</measure>
    <time_frame>1 Year</time_frame>
    <description>LR+ = sensitivity / (1-specificity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CT-Likelihood ratio-</measure>
    <time_frame>1 year</time_frame>
    <description>LR- = (1-sensitivity) / specificity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PET-CT-Likelihood ratio-</measure>
    <time_frame>1 year</time_frame>
    <description>LR- = (1-sensitivity) / specificity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CT-positive predictive value</measure>
    <time_frame>1 year</time_frame>
    <description>PPV =TP / (TP+ FP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PET-CT-positive predictive value</measure>
    <time_frame>1 year</time_frame>
    <description>PPV =TP / (TP+ FP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CT-negative predictive value</measure>
    <time_frame>1 year</time_frame>
    <description>TN/ (TN + FN)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PET-CT-negative predictive value</measure>
    <time_frame>1 year</time_frame>
    <description>TN/ (TN + FN)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CT-Diagnostic accuracy</measure>
    <time_frame>1 year</time_frame>
    <description>(TP+TN) / (TP+TN+FP+FN)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PET-CT-Diagnostic accuracy</measure>
    <time_frame>1 year</time_frame>
    <description>(TP+TN) / (TP+TN+FP+FN)</description>
  </secondary_outcome>
  <enrollment type="Actual">112</enrollment>
  <condition>Pleural Effusion, Malignant</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with a unilateral pleural effusion of unknown origin examined with the above&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Thoracocentesis&#xD;
&#xD;
          -  Chest X-ray&#xD;
&#xD;
          -  CT scanning&#xD;
&#xD;
          -  PET-CT scanning&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Missing data&#xD;
&#xD;
          -  Lung cancer&#xD;
&#xD;
          -  Thoracic malignancies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Naestved Hospital</name>
      <address>
        <city>Naestved</city>
        <zip>4700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naestved Hospital</name>
      <address>
        <city>Næstved</city>
        <zip>4700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>December 15, 2020</last_update_submitted>
  <last_update_submitted_qc>December 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Naestved Hospital</investigator_affiliation>
    <investigator_full_name>Simon Reuter</investigator_full_name>
    <investigator_title>MD, Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Positron emission thomography</keyword>
  <keyword>Computed tomography</keyword>
  <keyword>Sensitivity</keyword>
  <keyword>Specificity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion, Malignant</mesh_term>
    <mesh_term>Pleural Effusion</mesh_term>
  </condition_browse>
  <!-- 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/NCT03272997
org study id: PET-CT in UPE
nct id: NCT03272997
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators aim is to asses the diagnostic power of 18F-FDG PET-CT in discriminating
      malignant from nonmalignant causes in patients with a recurrent unilateral pleural effusion
      of unknown origin.
The investigators follow the STARD 2015 guideline for reporting diagnostic accuracy studies.

      The investigators will review the hospital's administrative database of patients who
      underwent a thoracocentesis from January 2013 to January 2015. Patients at Department of
      Respiratory Medicine, Zealand University Hospital, Roskilde and Department of Respiratory
      Medicine, Naestved Hospital, Region Zealand, Denmark (two large respiratory centres with
      specialised functions) is eligible for inclusion. Patients are included irrespective of
      cytology and chemical analysis.

      The investigators will review the patients' medical records and images retrospectively. To
      reduce the number of false negatives, the investigators complete a 1-year follow-up.

      Patients older than 16 years are included, irrespective of smoking history and comorbidities,
      if both thoracocenteses, chest x-ray, a CT-scanning and a PET-CT scanning is performed.
      Exclusion criteria are previously diagnosed lung cancer, thoracic malignancy or incomplete
      data.

      Classification of results The investigators chose the combination of investigations
      recommended by the internationally acknowledged BTS guideline, which is endorsed by the
      Danish Society of Respiratory Medicine. Thoracocentesis, chest x-ray, CT findings and PET-CT
      findings is categorized as either normal (i.e. not suggestive of any aetiology of the
      unilateral pleural effusion), suggestive of other lung pathology or suggestive of malignancy
      (i.e. representing a possible aetiology of the unilateral pleural effusion).

      The thoracocentesis is classified as malignant if cytological examination revealed malignant
      cells. The chest x-ray is classified as malignant if suspicion of malignant disease is not
      rejected. The CT findings are classified as malignant according to Leung et. al. for pleural
      abnormalities (circumferential pleural thickening, nodular pleural thickening, parietal
      pleural thickening > 1 cm and mediastinal pleural involvement) and The Fleischner Society for
      parenchymal abnormalities (nodules > 8 mm). The PET-CT findings are classified as malignant
      if any findings suspicious for malignancy.

      CT and PET-CT images, as well as the scan reports by the radiologist and the nuclear medicine
      physician, is reviewed by two experienced pulmonologists. They are blinded to all patient
      information, including final diagnosis.

      The final diagnosis, the reference standard, is extracted from the patients' medical records.
      When no diagnosis is found, two investigators agree on a consensus diagnosis based on all
      investigation results. If no reasonable diagnosis can be established based on the findings,
      the patient case is categorized as having no final diagnosis. These cases are treated as a
      worst-case scenario, i.e. patients with a malignant disease are treated as false negative,
      and patients without malignant disease are treated as false positive.

      Statistics Data are presented as frequencies and/or mean ± standard deviation (SD). Test
      characteristics were compared using McNemar's test with Bonferroni correction (two-sided
      level of significance < o.o5). Diagnostic power of thoracocentesis, chest x-ray, CT-scanning,
      PET-CT scanning and the combination are calculated. Diagnostic power is defined as true
      positive, true negative, false positive, false negative, sensitivity, specificity, likelihood
      ratio+, likelihood ratio-, positive predictive value (PPV), negative predictive value (NPV)
      and diagnostic accuracy (TP+TN)/(TP+FP+TN+FN).

      The combined sensitivity will be calculated using the formula:

      Sensitivitytest A + Sensitivitytest B + Sensitivitytest … - (Sensitivitytest A x
      Sensitivitytest B x Sensitivitytest …)

      The combined specificity will be calculated using the formula:

      Specificitytest A x Specificitytest B x Specificitytest… Data were analyzed using STATA
      (StataCorp LLC, Version 15.0, College Station, Texas, USA).
observational model: Cohort
time perspective: Retrospective
measure: Sensitivity PET-CT
time frame: 1 year
description: TP / (TP + FN)
measure: CT-Specificity
time frame: 1 year
description: TN / (TN+FP)
measure: PET-CT-Specificity
time frame: 1 year
description: TN / (TN+FP)
measure: CT-Sensitivity
time frame: 1 year
description: TP / (TP + FN)
measure: Comparison of the diagnostic power
time frame: 1 year
description: McNemars' test with Bonferroni
measure: CT-Likelihood ratio+
time frame: 1 Year
description: LR+ = sensitivity / (1-specificity)
measure: PET-CT-Likelihood ratio+
time frame: 1 Year
description: LR+ = sensitivity / (1-specificity)
measure: CT-Likelihood ratio-
time frame: 1 year
description: LR- = (1-sensitivity) / specificity
measure: PET-CT-Likelihood ratio-
time frame: 1 year
description: LR- = (1-sensitivity) / specificity
measure: CT-positive predictive value
time frame: 1 year
description: PPV =TP / (TP+ FP)
measure: PET-CT-positive predictive value
time frame: 1 year
description: PPV =TP / (TP+ FP)
measure: CT-negative predictive value
time frame: 1 year
description: TN/ (TN + FN)
measure: PET-CT-negative predictive value
time frame: 1 year
description: TN/ (TN + FN)
measure: CT-Diagnostic accuracy
time frame: 1 year
description: (TP+TN) / (TP+TN+FP+FN)
measure: PET-CT-Diagnostic accuracy
time frame: 1 year
description: (TP+TN) / (TP+TN+FP+FN)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Naestved Hospital
investigator full name: Simon Reuter
investigator title: MD, Principal investigator
mesh term: Pleural Effusion, Malignant
mesh term: Pleural Effusion