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
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
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
NCT ID
NCT03294746
First Posted
September 1, 2017
Last Updated
September 27, 2017
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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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