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Imaging Biomarker in Cancer Drug Induced ILD (ImageILD)

Primary Purpose

Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Clinical evaluations

Thoracic CT

About this trial

This is an interventional diagnostic trial for Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients focused on measuring Drug induced interstitial lung disease (DIILD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Clinical evaluations and Thoracic CT scan scoring of DIILD

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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

To evaluate the predictive value of change in the semi-quantitative CT score at 6 weeks relative to baseline (DIILD diagnosis) against change in pulmonary physiology measurements and patient reported outcome (respiratory and quality of life) at 6 months relative to baseline.

Full Information

NCT ID

NCT03294746

First Posted

September 1, 2017

Last Updated

September 27, 2017

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

1. Study Identification

Unique Protocol Identification Number

NCT03294746

Brief Title

Imaging Biomarker in Cancer Drug Induced ILD

Acronym

ImageILD

Official Title

Qualification of Imaging Methods to Assess Cancer Drug Induced Interstitial Lung Disease (ImageILD)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2018 (Anticipated)

Primary Completion Date

July 2021 (Anticipated)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients

Keywords

Drug induced interstitial lung disease (DIILD)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clinical evaluations and Thoracic CT scan scoring of DIILD

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

Clinical evaluations

Intervention Description

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

Intervention Name(s)

Thoracic CT

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

analyses will be performed 3.5 years after First Patient In

Secondary Outcome Measure Information:

Title

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).

Time Frame

analyses will be performed 3.5 years after First Patient In

Title

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

Description

Time Frame

analyses will be performed 3.5 years after First Patient In

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bianca Colleoni, PhD

Phone

+32 (0)2 774 15 70

bianca.colleoni@eortc.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kim Linton

Organizational Affiliation

The Christie NHS Foundation Trust, Manchester, United Kingdom

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All publications must comply with the terms specified in the EORTC Policy 009 "Release of Results and Publication Policy".

Learn more about this trial

Imaging Biomarker in Cancer Drug Induced ILD

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