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Imaging Biomarker in Cancer Drug Induced ILD (ImageILD)

Primary Purpose

Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinical evaluations
Thoracic CT
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients focused on measuring Drug induced interstitial lung disease (DIILD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • World health organization (WHO) performance status 0-2
  • Life expectancy > 6 months
  • Proven cancer diagnosis in a patient actively undergoing anti-cancer therapy
  • New onset symptoms (e.g. cough, fever, dyspnoea, and hypoxia) at any time during or within 4 weeks of the last dose of anti-cancer treatment
  • New onset radiological (CXR or CT) abnormalities within the lungs at any time during or within 4 weeks of the last dose of anti-cancer treatment (e.g. diffuse lung changes, infiltrative opacification in the periphery of the lung or ground glass changes) with a locally reviewed diagnosis of DIILD as the most likely explanation for the radiological abnormalities.
  • Treatment for DIILD planned (e.g. drug withdrawal, interruption +/- supportive therapy including corticosteroids, oxygen, bronchodilators etc.). Concomitant treatment with antibiotics, anticoagulants etc. is permitted pending results of investigations for differential diagnoses.
  • Able to undergo pulmonary function tests (at a minimum spirometry and gas transfer (DLCO))
  • Patients enrolled on other anti-cancer investigational trials are permitted at investigator discretion
  • Informed written consent obtained according to national/local regulations
  • Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 14 days before study registration

Exclusion Criteria:

  • Clinically suspected or confirmed radiological features of any malignancy involving the lungs at the time of study registration
  • Claustrophobia, or inability to undergo non-contrast CT examination
  • Known or suspected non-drug related ILD (e.g. lung abnormalities due to other causes such as occupational exposure)
  • Previous extensive thoracic surgery (e.g. lobectomy)
  • Clinical, radiological or microbiological evidence of active lower respiratory tract infection
  • Currently active, clinically significant heart disease, such as uncontrolled class 3 or 4 congestive heart failure defined by the New York Heart Association Functional Classification
  • Any medical, psychological, sociological or geographical condition that could affect participation in the study and compliance with the study protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Clinical evaluations and Thoracic CT scan scoring of DIILD

    Arm Description

    Outcomes

    Primary Outcome Measures

    Correlation coefficient between semi-quantitative CT score and FVC (forced vital capacity)
    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.

    Secondary Outcome Measures

    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).
    To evaluate the predictive value of change in the semi-quantitative CT score.
    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.

    Full Information

    First Posted
    September 1, 2017
    Last Updated
    September 27, 2017
    Sponsor
    European Organisation for Research and Treatment of Cancer - EORTC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03294746
    Brief Title
    Imaging Biomarker in Cancer Drug Induced ILD
    Acronym
    ImageILD
    Official Title
    Qualification of Imaging Methods to Assess Cancer Drug Induced Interstitial Lung Disease (ImageILD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2018 (Anticipated)
    Primary Completion Date
    July 2021 (Anticipated)
    Study Completion Date
    July 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    European Organisation for Research and Treatment of Cancer - EORTC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients
    Keywords
    Drug induced interstitial lung disease (DIILD)

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Clinical evaluations and Thoracic CT scan scoring of DIILD
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    Clinical evaluations
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    Thoracic CT
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Correlation coefficient between semi-quantitative CT score and FVC (forced vital capacity)
    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.
    Time Frame
    analyses will be performed 3.5 years after First Patient In
    Secondary Outcome Measure Information:
    Title
    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
    Title
    To evaluate the predictive value of change in the semi-quantitative CT score.
    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.
    Time Frame
    analyses will be performed 3.5 years after First Patient In

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years World health organization (WHO) performance status 0-2 Life expectancy > 6 months Proven cancer diagnosis in a patient actively undergoing anti-cancer therapy New onset symptoms (e.g. cough, fever, dyspnoea, and hypoxia) at any time during or within 4 weeks of the last dose of anti-cancer treatment New onset radiological (CXR or CT) abnormalities within the lungs at any time during or within 4 weeks of the last dose of anti-cancer treatment (e.g. diffuse lung changes, infiltrative opacification in the periphery of the lung or ground glass changes) with a locally reviewed diagnosis of DIILD as the most likely explanation for the radiological abnormalities. Treatment for DIILD planned (e.g. drug withdrawal, interruption +/- supportive therapy including corticosteroids, oxygen, bronchodilators etc.). Concomitant treatment with antibiotics, anticoagulants etc. is permitted pending results of investigations for differential diagnoses. Able to undergo pulmonary function tests (at a minimum spirometry and gas transfer (DLCO)) Patients enrolled on other anti-cancer investigational trials are permitted at investigator discretion Informed written consent obtained according to national/local regulations Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 14 days before study registration Exclusion Criteria: Clinically suspected or confirmed radiological features of any malignancy involving the lungs at the time of study registration Claustrophobia, or inability to undergo non-contrast CT examination Known or suspected non-drug related ILD (e.g. lung abnormalities due to other causes such as occupational exposure) Previous extensive thoracic surgery (e.g. lobectomy) Clinical, radiological or microbiological evidence of active lower respiratory tract infection Currently active, clinically significant heart disease, such as uncontrolled class 3 or 4 congestive heart failure defined by the New York Heart Association Functional Classification Any medical, psychological, sociological or geographical condition that could affect participation in the study and compliance with the study protocol
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bianca Colleoni, PhD
    Phone
    +32 (0)2 774 15 70
    Email
    bianca.colleoni@eortc.be
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kim Linton
    Organizational Affiliation
    The Christie NHS Foundation Trust, Manchester, United Kingdom
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    All publications must comply with the terms specified in the EORTC Policy 009 "Release of Results and Publication Policy".

    Learn more about this trial

    Imaging Biomarker in Cancer Drug Induced ILD

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