An interventional study of Clinical evaluations and Thoracic CT in Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-29.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Not applicable, Interventional, and Diagnostic
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.
Exclusion Criteria:
Other: Clinical evaluations · Other: Thoracic CT
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.
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.
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.
Time frame: analyses will be performed 3.5 years after First Patient In
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.
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
No study locations are listed for this record.
Plan to share: Yes — All publications must comply with the terms specified in the EORTC Policy 009 "Release of Results and Publication Policy".
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This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC