Clinical trial NCT03294746: Imaging Biomarker in Cancer Drug Induced ILD
Official title: Qualification of Imaging Methods to Assess Cancer Drug Induced Interstitial Lung Disease (ImageILD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients
Keywords: Drug induced interstitial lung disease (DIILD)
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2017-09-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Correlation coefficient between semi-quantitative CT score and FVC (forced vital capacity)
timeFrame: analyses will be performed 3.5 years after First Patient In
Secondary outcomes:
measure: 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).
timeFrame: analyses will be performed 3.5 years after First Patient In
measure: To evaluate the predictive value of change in the semi-quantitative CT score.
timeFrame: analyses will be performed 3.5 years after First Patient In
Other outcomes:
Locations:
Study officials:
affiliation: The Christie NHS Foundation Trust, Manchester, United Kingdom
name: Kim Linton
role: PRINCIPAL_INVESTIGATOR
References: