Imaging Biomarker in Cancer Drug Induced ILD

NCT03294746 | Unknown DMC

• 1 other identifier: EORTC-1658-IG
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (1)

• Correlation coefficient between semi-quantitative CT score and FVC (forced vital capacity)

  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.

  analyses will be performed 3.5 years after First Patient In

Secondary Outcomes (2)

• 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).

  analyses will be performed 3.5 years after First Patient In

• To evaluate the predictive value of change in the semi-quantitative CT score.

  analyses will be performed 3.5 years after First Patient In

Study Arms (1)

Clinical evaluations and Thoracic CT scan scoring of DIILD

OTHER

Other: Clinical evaluations; Other: Thoracic CT

Interventions

Clinical evaluations 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.

Clinical evaluations and Thoracic CT scan scoring of DIILD

Thoracic CT 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.

Clinical evaluations and Thoracic CT scan scoring of DIILD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Officials

• Kim Linton

  The Christie NHS Foundation Trust, Manchester, United Kingdom

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bianca Colleoni, PhD

CONTACT

+32 (0)2 774 15 70; bianca.colleoni@eortc.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 27, 2017
• Study Start: January 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 29, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share