Table 1

Amendments to date

Amendment numberPrevious protocol versionPrevious dateNew protocol versionNew dateSummary of changeDate of ethical approval
11.012 May 2015Not applicableNot applicableNo changes to the protocol.
Changes to the patient information sheet (PIS) to reflect changes requested by Administration of Radioactive Substances Advisory Committee to change wording and clarification when the fluorodeoxyglucose would be out of the system.
14 September 2015
21.012 May 20153.014 January 2016A previously planned MRI element to the trial was removed.
The patient consent form will be uploaded into the National Health Service secure database.
Version 2.0 was submitted to the Research Ethics Committee (REC) on the 23 December 2015. However, before this version was approved by the REC, additional changes were made to the protocol and resubmitted as version 3.0 dated 15 December 2016.
02 February 2016
33.014 January 20164.023 May 2016Exclusion criteria changed from ‘pleural thickening not amenable to Tru cut biopsy’ to ‘pleural thickening not amenable to radiologically guided biopsy’
If as a direct result of the positron emission tomography (PET) results, the radiologist feels a pleural biopsy is no longer possible and/or another more easily and safely accessible area has been identified as a result of the PET, then this area should be biopsied instead.
Expected serious adverse events relating to disease progression were added to the protocol.
21 June/2016
44.023 May 20165.010 October 2016Addition of new sites
Before this amendment could be reviewed by the Ethics committee, we submitted another amendment (see below); they were both reviewed together and approved on 02 December 2016
Not applicable
55.010 October 20166.028 October 2016Change to inclusion criterion ‘any form of pleural biopsy in the previous 6 months’ to ‘any form of pleural biopsy in the previous 12 months’.
Change to exclusion criterion ‘prior Talc pleurodesis’ has been changed to ‘Talc pleurodesis in the previous 6 months’
02 December 2016
56.017 August 20177.017 August 2017To increase the recruitment period by 6 months. Patients that were randomised into the study before 4 September 2017 will be followed up for 12 months. Patients randomised after that date will be followed up until 3 September 2018—close of study.11 September 2017