A pilot study to assess feasibility, safety and efficacy of artificially introducing an air-pleura interface for detection of pleural nodules by computed tomography

Not Applicable

• Conditions: Pleural malignancy; Pleural disease; Respiratory - Other respiratory disorders / diseases; Cancer - Lung - Mesothelioma; Cancer - Lung - Non small cell

• Registration Number: ACTRN12615000337572
• Lead Sponsor: Prof YC Gary Lee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To confirm the safety of creating an artificial air-pleura interface by introducing air into the pleural space via a previously inserted chest drain.<br><br>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.<br><br>[2 weeks post-CT scan]