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
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)|
|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|
|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.
- 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.
- 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.
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
|Contact: Bianca Colleoni, PhD||+32 (0)2 774 15 firstname.lastname@example.org|
|Principal Investigator:||Kim Linton||The Christie NHS Foundation Trust, Manchester, United Kingdom|