Qualification of imaging methods to assess cancer drug induced interstitial lung disease (ImageILD)

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

* Age * 18 years
* WHO performance status 0-2
* Life expectancy > 6 months
* Proven cancer diagnosis in a patient actively undergoing systemic anticancer
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.).
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 ICH/GCP, and
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

* Primary lung tumor greater than 3cm
* Lung metastatic lesion > 2cm or greater than 5 metastases
* 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 thoracic 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Relative change of FVC between study entry (DIILD diagnosis) and 6 weeks after<br /><br>diagnosis (treatment adaptation)<br /><br>- Relative change in the semi-quantitative radiology scores between study entry<br /><br>(DIILD diagnosis) and 6 weeks after diagnosed DIILD (treatment adaptation)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To be evaluated at study entry, at 6 weeks and 6 months:<br /><br>* FVC<br /><br>* Other pulmonary physiology results (e.g. DLCO and 6MWT)<br /><br>* Respiratory patient report outcome<br /><br>* Quality of life<br /><br>To be evaluated at study entry and at 6 weeks:<br /><br>* Radiology qualitative analysis (3 grading)<br /><br>* Quantitative volumetric inspiratory CT measurements</p><br>