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Imaging Biomarker in Cancer Drug Induced ILD (ImageILD)

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ClinicalTrials.gov Identifier: NCT03294746
Recruitment Status : Not yet recruiting
First Posted : September 27, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.


Condition or disease Intervention/treatment Phase
Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients Other: Clinical evaluations Other: Thoracic CT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Qualification of Imaging Methods to Assess Cancer Drug Induced Interstitial Lung Disease (ImageILD)
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Clinical evaluations and Thoracic CT scan scoring of DIILD Other: Clinical evaluations
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.

Other: Thoracic CT
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 Measures :
  1. 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 ]
    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 :
  1. 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 ]
  2. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294746


Contacts
Contact: Bianca Colleoni, PhD +32 (0)2 774 15 70 bianca.colleoni@eortc.be

Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Principal Investigator: Kim Linton The Christie NHS Foundation Trust, Manchester, United Kingdom

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT03294746     History of Changes
Other Study ID Numbers: EORTC-1658-IG
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All publications must comply with the terms specified in the EORTC Policy 009 "Release of Results and Publication Policy".

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
Drug induced interstitial lung disease (DIILD)

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Antineoplastic Agents