<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/NCT03294746</url>
  </required_header>
  <id_info>
    <org_study_id>EORTC-1658-IG</org_study_id>
    <nct_id>NCT03294746</nct_id>
  </id_info>
  <brief_title>Imaging Biomarker in Cancer Drug Induced ILD</brief_title>
  <acronym>ImageILD</acronym>
  <official_title>Qualification of Imaging Methods to Assess Cancer Drug Induced Interstitial Lung Disease (ImageILD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Organisation for Research and Treatment of Cancer - EORTC</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Drug induced interstitial lung disease (DIILD) is caused by iatrogenic injury to the lung&#xD;
      parenchyma and can be caused by over four hundred different drugs in humans. Diagnosing DIILD&#xD;
      is a challenge for clinicians and radiologists as a positive diagnosis depends on exclusion&#xD;
      of other causes including respiratory infection, occupational, recreational, and&#xD;
      environmental exposures, specific respiratory disorders, and systemic diseases.&#xD;
&#xD;
      The aim of this study is to qualify an objective CT scoring system for DIILD assessment. In&#xD;
      addition, the quantitative information obtained from CT scans with densitometry and texture&#xD;
      analysis will be explored.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2018</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</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>Correlation coefficient between semi-quantitative CT score and FVC (forced vital capacity)</measure>
    <time_frame>analyses will be performed 3.5 years after First Patient In</time_frame>
    <description>The primary objective of the study is to qualify an objective semi-quantitative CT scoring system looking at the correlation between the change in the semi-quantitative CT score at 6 weeks relative to baseline (DIILD diagnosis) against the change in Forced vital capacity (FVC) at 6 weeks relative to baseline (DIILD diagnosis). The semi-quantitative CT score will be calculated based on CT features: 1)ground-glass opacity 2) reticular/septal lines 3) honeycombing 4) nodular opacity 5) consolidation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation coefficient between the semi-quantitative CT score with the other pulmonary physiology measurements (DLCO and 6WMT) and patient reported outcome (respiratory and quality of life).</measure>
    <time_frame>analyses will be performed 3.5 years after First Patient In</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the predictive value of change in the semi-quantitative CT score.</measure>
    <time_frame>analyses will be performed 3.5 years after First Patient In</time_frame>
    <description>To evaluate the predictive value of change in the semi-quantitative CT score at 6 weeks relative to baseline (DIILD diagnosis) against change in pulmonary physiology measurements and patient reported outcome (respiratory and quality of life) at 6 months relative to baseline.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients</condition>
  <arm_group>
    <arm_group_label>Clinical evaluations and Thoracic CT scan scoring of DIILD</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical evaluations</intervention_name>
    <description>At study entry , 6 weeks and 6 months, enrolled patients will undergo pulmonary physiology tests, assessment of respiratory symptoms, respiratory examination, pulse oximetry, blood draws, respiratory and quality of life assessment. Data from bronchoscopy assessments will be collected, if this has been performed as part of routine care.</description>
    <arm_group_label>Clinical evaluations and Thoracic CT scan scoring of DIILD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Thoracic CT</intervention_name>
    <description>At study entry, patients will undergo thoracic CT before treatment adaptation, unless a study-quality scan* has already been performed . Thoracic CT will be repeated at 6 weeks. All images will be centrally reviewed for radiology scoring.</description>
    <arm_group_label>Clinical evaluations and Thoracic CT scan scoring of DIILD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  World health organization (WHO) performance status 0-2&#xD;
&#xD;
          -  Life expectancy &gt; 6 months&#xD;
&#xD;
          -  Proven cancer diagnosis in a patient actively undergoing anti-cancer therapy&#xD;
&#xD;
          -  New onset symptoms (e.g. cough, fever, dyspnoea, and hypoxia) at any time during or&#xD;
             within 4 weeks of the last dose of anti-cancer treatment&#xD;
&#xD;
          -  New onset radiological (CXR or CT) abnormalities within the lungs at any time during&#xD;
             or within 4 weeks of the last dose of anti-cancer treatment (e.g. diffuse lung&#xD;
             changes, infiltrative opacification in the periphery of the lung or ground glass&#xD;
             changes) with a locally reviewed diagnosis of DIILD as the most likely explanation for&#xD;
             the radiological abnormalities.&#xD;
&#xD;
          -  Treatment for DIILD planned (e.g. drug withdrawal, interruption +/- supportive therapy&#xD;
             including corticosteroids, oxygen, bronchodilators etc.). Concomitant treatment with&#xD;
             antibiotics, anticoagulants etc. is permitted pending results of investigations for&#xD;
             differential diagnoses.&#xD;
&#xD;
          -  Able to undergo pulmonary function tests (at a minimum spirometry and gas transfer&#xD;
             (DLCO))&#xD;
&#xD;
          -  Patients enrolled on other anti-cancer investigational trials are permitted at&#xD;
             investigator discretion&#xD;
&#xD;
          -  Informed written consent obtained according to national/local regulations&#xD;
&#xD;
          -  Women of child bearing potential (WOCBP) must have a negative serum (or urine)&#xD;
             pregnancy test within 14 days before study registration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically suspected or confirmed radiological features of any malignancy involving&#xD;
             the lungs at the time of study registration&#xD;
&#xD;
          -  Claustrophobia, or inability to undergo non-contrast CT examination&#xD;
&#xD;
          -  Known or suspected non-drug related ILD (e.g. lung abnormalities due to other causes&#xD;
             such as occupational exposure)&#xD;
&#xD;
          -  Previous extensive thoracic surgery (e.g. lobectomy)&#xD;
&#xD;
          -  Clinical, radiological or microbiological evidence of active lower respiratory tract&#xD;
             infection&#xD;
&#xD;
          -  Currently active, clinically significant heart disease, such as uncontrolled class 3&#xD;
             or 4 congestive heart failure defined by the New York Heart Association Functional&#xD;
             Classification&#xD;
&#xD;
          -  Any medical, psychological, sociological or geographical condition that could affect&#xD;
             participation in the study and compliance with the study protocol&#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>Kim Linton</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Christie NHS Foundation Trust, Manchester, United Kingdom</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bianca Colleoni, PhD</last_name>
    <phone>+32 (0)2 774 15 70</phone>
    <email>bianca.colleoni@eortc.be</email>
  </overall_contact>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug induced interstitial lung disease (DIILD)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All publications must comply with the terms specified in the EORTC Policy 009 &quot;Release of Results and Publication Policy&quot;.</ipd_description>
  </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/NCT03294746
org study id: EORTC-1658-IG
nct id: NCT03294746
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Drug induced interstitial lung disease (DIILD) is caused by iatrogenic injury to the lung
      parenchyma and can be caused by over four hundred different drugs in humans. Diagnosing DIILD
      is a challenge for clinicians and radiologists as a positive diagnosis depends on exclusion
      of other causes including respiratory infection, occupational, recreational, and
      environmental exposures, specific respiratory disorders, and systemic diseases.

      The aim of this study is to qualify an objective CT scoring system for DIILD assessment. In
      addition, the quantitative information obtained from CT scans with densitometry and texture
      analysis will be explored.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Correlation coefficient between semi-quantitative CT score and FVC (forced vital capacity)
time frame: analyses will be performed 3.5 years after First Patient In
description: The primary objective of the study is to qualify an objective semi-quantitative CT scoring system looking at the correlation between the change in the semi-quantitative CT score at 6 weeks relative to baseline (DIILD diagnosis) against the change in Forced vital capacity (FVC) at 6 weeks relative to baseline (DIILD diagnosis). The semi-quantitative CT score will be calculated based on CT features: 1)ground-glass opacity 2) reticular/septal lines 3) honeycombing 4) nodular opacity 5) consolidation.
measure: Correlation coefficient between the semi-quantitative CT score with the other pulmonary physiology measurements (DLCO and 6WMT) and patient reported outcome (respiratory and quality of life).
time frame: analyses will be performed 3.5 years after First Patient In
measure: To evaluate the predictive value of change in the semi-quantitative CT score.
time frame: analyses will be performed 3.5 years after First Patient In
description: To evaluate the predictive value of change in the semi-quantitative CT score at 6 weeks relative to baseline (DIILD diagnosis) against change in pulmonary physiology measurements and patient reported outcome (respiratory and quality of life) at 6 months relative to baseline.
arm group label: Clinical evaluations and Thoracic CT scan scoring of DIILD
arm group type: Other
intervention type: Other
intervention name: Clinical evaluations
description: At study entry , 6 weeks and 6 months, enrolled patients will undergo pulmonary physiology tests, assessment of respiratory symptoms, respiratory examination, pulse oximetry, blood draws, respiratory and quality of life assessment. Data from bronchoscopy assessments will be collected, if this has been performed as part of routine care.
arm group label: Clinical evaluations and Thoracic CT scan scoring of DIILD
intervention type: Other
intervention name: Thoracic CT
description: At study entry, patients will undergo thoracic CT before treatment adaptation, unless a study-quality scan* has already been performed . Thoracic CT will be repeated at 6 weeks. All images will be centrally reviewed for radiology scoring.
arm group label: Clinical evaluations and Thoracic CT scan scoring of DIILD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kim Linton
role: Principal Investigator
affiliation: The Christie NHS Foundation Trust, Manchester, United Kingdom
last name: Bianca Colleoni, PhD
phone: +32 (0)2 774 15 70
email: bianca.colleoni@eortc.be
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial
sharing ipd: Yes
ipd description: All publications must comply with the terms specified in the EORTC Policy 009 "Release of Results and Publication Policy".