NCT03294746

Imaging Biomarker in Cancer Drug Induced ILD

Qualification of Imaging Methods to Assess Cancer Drug Induced Interstitial Lung Disease (ImageILD)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2017-09-27
• Last updated: 2017-09-29