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)

Our plain-English summary of 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), by D. de Fonseka, W. Underwood, L. Stadon, et al (BMJ Open Respiratory Research, 2018).

The study

• Authors: D. de Fonseka, W. Underwood, L. Stadon, N. Rahman, A. Edey, C. Rogers, N.A. Maskell
• Journal: BMJ Open Respiratory Research
• Published: 2018;5(1):e000270
• Cited by: 25 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

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: ISRCTN 14024829; Pre-results.

In plain English

This article is the protocol of the TARGET trial, a randomised controlled trial in the UK; it describes the trial plan and reports no results. The trial was designed for adults whose CT scans showed thickening of the pleura (the lining around the lungs) suspicious for pleural malignancy, and whose pleural biopsy in the previous 12 months had not shown cancer. It aimed to recruit 78 patients from 10 centres. Patients were to be randomly assigned to a second standard CT-guided biopsy, or to a PET-CT scan followed by a CT-guided biopsy aimed at an area shown on it. The main outcome was whether the second biopsy correctly identified pleural malignancy. Follow-up was to last 12 months, or 6 months for patients recruited in the final 6 months. Mesothelin, a blood marker, was to be measured at baseline and at 6- and 12-month visits in patients able to attend. The authors hypothesised that targeting biopsies to areas of high uptake of a glucose tracer on PET might improve diagnostic yield. Recruitment opened in September 2015 and was due to finish in March 2018.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Protocol for a UK multicentre parallel-group randomised controlled trial; no results reported
• Who was studied: Planned: 78 adults (age 18 or over) from 10 UK centres, with pleural thickening on CT suspicious for pleural malignancy, a non-diagnostic pleural biopsy in the previous 12 months, and a multidisciplinary team decision to perform a further CT-guided biopsy. Recruitment opened September 2015 and was due to complete March 2018.
• Exposure: Diagnostic procedure compared: PET-CT scan followed by a targeted CT-guided pleural biopsy, versus a standard second CT-guided biopsy. Asbestos exposure itself was not studied.
• The authors' conclusion: No conclusions; the trial had not yet reported. The authors hypothesised that targeting the CT-guided biopsy to areas of high FDG uptake on PET may improve the diagnostic yield.

Topics

Medical terms in this study, explained in our Lexicon: PET-CT, Pleural Biopsy, Pleural Mesothelioma, Latency, Pleural Effusion, Biopsy, CT Scan, Biomarker.

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