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Imaging Biomarker in Cancer Drug Induced ILD (ImageILD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 1, 2017
First Posted Date  ICMJE September 27, 2017
Last Update Posted Date September 29, 2017
Estimated Study Start Date  ICMJE January 2018
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
  • 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 ]
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imaging Biomarker in Cancer Drug Induced ILD
Official Title  ICMJE Qualification of Imaging Methods to Assess Cancer Drug Induced Interstitial Lung Disease (ImageILD)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Clinical evaluations and Thoracic CT scan scoring of DIILD
Interventions:
  • Other: Clinical evaluations
  • Other: Thoracic CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2017)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bianca Colleoni, PhD +32 (0)2 774 15 70 bianca.colleoni@eortc.be
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03294746
Other Study ID Numbers  ICMJE EORTC-1658-IG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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".
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kim Linton The Christie NHS Foundation Trust, Manchester, United Kingdom
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP