Randomised controlled trial to compare the diagnostic yield of Positron Emission Tomography Computerised Tomography (PET CT) targeted pleural biopsy versus CT-guided pleural biopsy in suspected pleural malignancy

orth Bristol NHS Trust0 sites78 target enrollmentJanuary 27, 2016

Overview

Registry

who.int

Start Date

January 27, 2016

End Date

September 30, 2019

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

orth Bristol NHS Trust

•Current participant inclusion criteria as of 17/11/2017:
•Participants may be eligible for the study if ALL the following apply:
•1\. Pleural thickening on CT suspicious for pleural malignancy
•2\. Have had any form of pleural biopsy in the last 12 months (either by thoracoscopy or under radiological guidance) which was non\-diagnostic for cancer
•3\. Lung Cancer/mesothelioma MDT decision to perform further CT\-guided biopsy to pursue a diagnosis
•Previous participant inclusion criteria:
•1\. Aged 18 years or over
•2\. Pleural thickening on CT suspicious for malignancy
•3\. Have had any for of pleural biopsy in the last 6 months (either by thoracoscopy or under radiological guidance) which was nondiagnostic for cancer
•4\. Lung Cancer/Mesothelioma Multidisciplinary team (MDT) decision to perform further CT guided biopsy to pursue a diagnosis

•Current exclusion criteria as of 17/11/2017:
•Participants may not enter study if ANY of the following apply:
•1\. Unsuitable for a CT guided biopsy – inability to co\-operate, lie still for the duration of the biopsy, uncorrectable coagulopathy, inability to tolerate a pneumothorax, severe underlying lung disease (patients with an FEV1 \< 35% assessed using simple spirometry, see section 5\.3\.1\)
•2\. Unable to give written informed consent
•3\. Pregnancy or lactation
•4\. Age \<18 years
•5\. Pleural thickening not amenable to a radiologically guided biopsy
•6\. Talc pleurodesis in the previous 6 months
•Previous exclusion criteria:
•1\. Unsuitable for CT guided biopsy inability to cooperate, lie still for the duration of the biopsy, uncorrectable coagulopathy, inability to tolerate a pneumothorax, severe underlying lung disease (patients with an FEV1 \<35% assessed using simple spirometry)