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Randomised controlled trial to compare the diagnostic yield of positron emission tomography CT (PET-CT) TARGETed pleural biopsy versus CT-guided pleural biopsy in suspected pleural malignancy (TARGET trial)
  1. Duneesha de Fonseka1,
  2. Wendy Underwood2,
  3. Louise Stadon3,
  4. Najib Rahman4,
  5. Anthony Edey5,
  6. Chris Rogers2 and
  7. Nick A Maskell1
  1. 1 Academic Respiratory Unit, University of Bristol, Bristol, UK
  2. 2 Clinical Trials and Evaluation Unit, University of Bristol, Bristol, UK
  3. 3 Academic Respiratory Unit, North Bristol NHS Trust, Bristol, UK
  4. 4 Oxford Centre for Respiratory Medicine and Oxford NIHR Biomedical Research Centre, Churchill Hospital, Oxford, UK
  5. 5 Department of Radiology, North Bristol NHS Trust, Bristol, UK
  1. Correspondence to Dr Duneesha de Fonseka; Duneesha{at}gmail.com

Abstract

Introduction Pleural malignancy, particularly malignant pleural mesothelioma (MPM) is increasing in incidence due to the long latency period from exposure to asbestos to development of the disease. MPM can be challenging to diagnose. For patients presenting without a pleural effusion, CT-guided biopsy remains the primary choice of biopsy, but the diagnostic sensitivity of this investigation is 70%–75%. Therefore, a proportion of patients will go on to require further biopsies. If the first biopsy is non-diagnostic, the chances of further non-diagnostic biopsies are high in MPM.

Methods Target is a multicentre randomised controlled trial, aiming to recruit 78 patients over a 30-month period, from 10 centres in the UK. Patients will be randomised to either the standard arm which is a second CT-guided biopsy, or the interventional arm, a positron emission tomography-CT scan followed by a targeted CT-guided biopsy. Patients will be followed up for 12 months (patients recruited in the last 6 months of recruitment will have 6 months of follow-up). MPM biomarker mesothelin will be checked at baseline, 6 month and 12 month follow-up appointments where patients are able to attend these appointments.

Ethics and dissemination Ethical approval for this trial was granted by the South West—Exeter research and ethics committee (reference number 15/SW/0156). Results of the trial will be published in a peer-reviewed journal and presented at an international conference.

Trial registration number ISRCTN14024829; Pre-results.

  • mesothelioma
  • pleural disease
  • imaging/CT MRI etc

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors DdF is the trial coordinator for the trial, WU is the trial manager and LS is the research nurse. AE is the lead radiologist for the trial. CR provides statistical input. NR is a PI at one of the recruiting centres and a TSC member. NAM is the chief investigator. DdF drafted the initial manuscript while all other authors reviewed and worked on the final version.

  • Funding National Institute for Health Research (NIHR) Research for patient benefit (RfPB) funding stream. Reference PB-PG-0214-33095

  • Competing interests None declared.

  • Ethics approval South West (Exeter) Research Ethics Committee.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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