Status:
UNKNOWN
Imaging Biomarker in Cancer Drug Induced ILD
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients
Eligibility:
All Genders
18+ years
Phase:
NA
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03294746
Start Date
January 1 2018
End Date
July 1 2021
Last Update
September 29 2017
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