Drug Induced Interstitial Lung Disease (DIILD) Cancer PatientsImageILDNCT03294746
Imaging Biomarker in Cancer Drug Induced ILD
A study testing Clinical evaluations and Thoracic CT in people with Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients, run by European Organisation for Research and Treatment of Cancer - EORTC.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients
- What is being tested?
- Clinical evaluations and Thoracic CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Qualification of Imaging Methods to Assess Cancer Drug Induced Interstitial Lung Disease (ImageILD)
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.
- Being tested
- Clinical evaluations, Thoracic CT
- Keywords
- Drug induced interstitial lung disease (DIILD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluationsOther
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 CTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical evaluations and Thoracic CT scan scoring of DIILD | Other | Not described Receives: Other: Clinical evaluations; Other: Thoracic CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: analyses will be performed 3.5 years after First Patient In
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.
Measured: analyses will be performed 3.5 years after First Patient In
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study startJan 2018 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Induced Interstitial Lung Disease (DIILD) Cancer PatientsStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Kim Linton, Principal investigator, The Christie NHS Foundation Trust, Manchester, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294746
- Sponsor's protocol ID
- EORTC-1658-IG
- Acronym
- ImageILD
- Status last verified
- Sep 2017
- First submitted
- 1 Sep 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All publications must comply with the terms specified in the EORTC Policy 009 "Release of Results and Publication Policy".
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualification of Imaging Methods to Assess Cancer Drug Induced Interstitial Lung Disease (ImageILD)
- ClinicalTrials.gov ID
- NCT03294746
- Acronym / sponsor ID
- ImageILD / EORTC-1658-IG
- Keywords
- Drug induced interstitial lung disease (DIILD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical evaluations and Thoracic CT scan scoring of DIILD | Other | Other: Clinical evaluations, Other: Thoracic CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical evaluationsAt 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. | Other | Clinical evaluations and Thoracic CT scan scoring of DIILD |
| Thoracic CTAt 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. | Other | Clinical evaluations and Thoracic CT scan scoring of DIILD |
Primary outcome
Correlation coefficient between semi-quantitative CT score and FVC (forced vital capacity)
Time frame: analyses will be performed 3.5 years after First Patient In
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.
2 secondary outcomes
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
To evaluate the predictive value of change in the semi-quantitative CT score.
Time frame: analyses will be performed 3.5 years after First Patient In
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Individual participant dataSharing planned: Yes. All publications must comply with the terms specified in the EORTC Policy 009 "Release of Results and Publication Policy".
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Linton principal investigator
The Christie NHS Foundation Trust, Manchester, United Kingdom
Questions about this trial
What is this clinical trial studying?
A study testing Clinical evaluations and Thoracic CT in people with Drug Induced Interstitial Lung Disease (DIILD) Cancer Patients, run by European Organisation for Research and Treatment of Cancer - EORTC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bianca Colleoni, PhD (+32 (0)2 774 15 70, bianca.colleoni@eortc.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient between semi-quantitative CT score and FVC (forced vital capacity) (time frame: analyses will be performed 3.5 years after First Patient In). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.