Imaging Biomarker in Cancer Drug Induced ILD

NCT ID: NCT03294746

Last Updated: 2017-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2021-07-31

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.

Conditions

Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients

Keywords

Drug induced interstitial lung disease (DIILD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Clinical evaluations and Thoracic CT scan scoring of DIILD

Group Type: OTHER

Clinical evaluations

Intervention Type: OTHER

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.

Thoracic CT

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kim Linton

Role: PRINCIPAL_INVESTIGATOR

The Christie NHS Foundation Trust, Manchester, United Kingdom

Central Contacts

Bianca Colleoni, PhD

Role: CONTACT

Phone: +32 (0)2 774 15 70

Email: bianca.colleoni@eortc.be

Other Identifiers

EORTC-1658-IG

Identifier Type: -

Identifier Source: org_study_id