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Trial registered on ANZCTR


Registration number
ACTRN12615000337572
Ethics application status
Approved
Date submitted
15/03/2015
Date registered
14/04/2015
Date last updated
17/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to assess feasibility, safety and efficacy of artificially introducing an air-pleura interface for detection of pleural nodules by computed tomography
Scientific title
Feasibility, safety and efficacy of using artificial pneumothorax to detect pleural abnormalities by computed tomography - A pilot study
Secondary ID [1] 286357 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pleural malignancy 294490 0
Pleural disease 294491 0
Condition category
Condition code
Respiratory 294793 294793 0 0
Other respiratory disorders / diseases
Cancer 294846 294846 0 0
Lung - Mesothelioma
Cancer 294847 294847 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with suspected or proven MPE undergoing a standard CT scan examination as part of routine clinical management will be included in this study. Immediately after the first standard CT scan an artificial air-pleura interface will be created by introducing 500mL of air via an in-situ chest drain [such as intercostal catheter (ICC) or indwelling pleural catheter (IPC)]. The air is introduced using a syringe connected to the chest drain. A second CT scan will be performed immediately afterwards. The abnormal findings on pleura detected by the two CT scans will be compared. The approximate duration for the procedure and scan will be approximately 15 minutes.
Intervention code [1] 291419 0
Diagnosis / Prognosis
Comparator / control treatment
The abnormal findings on pleura detected by the two CT scans will be compared.
Control group
Active

Outcomes
Primary outcome [1] 294546 0
To confirm the safety of creating an artificial air-pleura interface by introducing air into the pleural space via a previously inserted chest drain.

All adverse events relating to the trial procedure occurring during the course of the clinical study (i.e., from signing the informed consent until death or the end of the study follow up period (whichever comes first) will be collected and documented by the investigator according to the specific definitions and instructions detailed in the ‘Adverse Event Reporting’ section of the Trial Master File. Cases will also be reported if a causal link between the AE and the trial procedure is suspected but not confirmed.
Timepoint [1] 294546 0
2 weeks post-CT scan
Secondary outcome [1] 313598 0
To compare the effectiveness of a CT scan in the presence of an air-pleura interface with standard CT scan to detect small pleural nodules/other pleural abnormalities.

The control for the study CT scan will be first contrast-enhanced CT scan, the current best available ‘standard of care’ imaging. Each CT will be divided into two studies to report - "supine pleural phase CT with no air-pleura interface" and "prone CT with air-pleura interface". 2 chest radiologists will independently read the CTs to assess for the presence of pleural nodules, thickening or other abnormalities. The reporting radiologists will not be blinded to the type of CT but in order to reduce bias they will report the CT scans with and without air-pleura interface in a random order. As it is a new technique the degree of inter-rater agreement between the radiologists is important and therefore kappa statistics will be used to assess concordance between categorical outcomes and Bland Altman plots for continuous outcomes.
Timepoint [1] 313598 0
2 weeks post-CT scan

Eligibility
Key inclusion criteria
1. Patient with known or suspected malignant pleural effusion,

1.1. Who as part of his/her standard clinical care,
a) has a previously inserted chest drain in-situ, and
b) requires a standard CT scan.

1.2. Does not have evidence of advanced, pleural malignancy or abnormalities on their previous CT scan.

2. Will be able to undergo CT scan procedure.
3. Is able to comply with the protocol.
4. Is able to give written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age < 18 years.
2. Respiratory distress or oxygen saturation less than 92% on room air or FEV1 less than 50% on spirometry.
3. Patients unable to tolerate CT scanning (unable to lie supine or prone, renal failure, claustrophobia, contrast allergy).
4. Patients who are pregnant or lactating.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3565 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment outside Australia
Country [1] 6752 0
New Zealand
State/province [1] 6752 0

Funding & Sponsors
Funding source category [1] 290928 0
Other Collaborative groups
Name [1] 290928 0
Lung Institute of Western Australia
Country [1] 290928 0
Australia
Primary sponsor type
Individual
Name
Prof YC Gary Lee
Address
UWA School of Medicine & Pharmacology,
533, Harry Perkins Research Building,
QE II Medical Centre,
Perth, WA 6009, Australia
Country
Australia
Secondary sponsor category [1] 289614 0
None
Name [1] 289614 0
Address [1] 289614 0
Country [1] 289614 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292535 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 292535 0
Ethics committee country [1] 292535 0
Australia
Date submitted for ethics approval [1] 292535 0
Approval date [1] 292535 0
15/12/2014
Ethics approval number [1] 292535 0

Summary
Brief summary
This study will evaluate the use of an artificial air-pleura interface by introducing air into the chest for a computed tomography (CT) scan to detect abnormalities in patients with known or suspected malignant pleural effusion.
Who is it for? You may be eligible to join this study if you are aged 18 years or above, have known or suspected malignant pleural effusion and have a chest drain in-situ.
Study details: All participants will have two CT scans: one standard CT scan and one CT scan with an artificial air-pleura interface. The artificial air-pleura interface will be created by introducing 500mL of air via an in-situ chest drain [such as intercostal catheter (ICC) or indwelling pleural catheter (IPC)]. The air is introduced using a syringe connected to the chest drain. The findings on pleura detected by the two CT scans will be compared. No previous studies have specifically assessed pleural abnormalities through this technique. We hypothesize for this study that artificially creating an air-pleura interface will make the small pleural nodules (~1cm) more conspicuous and will allow significantly better detection of previously undetectable pleural abnormalities/ nodules by CT scan.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55794 0
Prof YC Gary Lee
Address 55794 0
UWA School of Medicine & Pharmacology,
533, Harry Perkins Research Building,
QE II Medical Centre,
Perth, WA 6009, Australia
Country 55794 0
Australia
Phone 55794 0
+61 8 61510913
Fax 55794 0
Email 55794 0
[email protected]
Contact person for public queries
Name 55795 0
YC Gary Lee
Address 55795 0
UWA School of Medicine & Pharmacology,
533, Harry Perkins Research Building,
QE II Medical Centre,
Perth, WA 6009, Australia
Country 55795 0
Australia
Phone 55795 0
+61 8 61510913
Fax 55795 0
Email 55795 0
[email protected]
Contact person for scientific queries
Name 55796 0
YC Gary Lee
Address 55796 0
UWA School of Medicine & Pharmacology,
533, Harry Perkins Research Building,
QE II Medical Centre,
Perth, WA 6009, Australia
Country 55796 0
Australia
Phone 55796 0
+61 8 61510913
Fax 55796 0
Email 55796 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseManagement of Malignant Pleural Effusions-- What Is New.2019https://dx.doi.org/10.1055/s-0039-1698285
N.B. These documents automatically identified may not have been verified by the study sponsor.