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)

Abstract

IntroductionPleural 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.MethodsTarget 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 disseminationEthical 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 numberISRCTN14024829; Pre-results.

Diagnostics in Pleural Disease

“…The TARGET study set out to specifically assess the role of PET-CT-guided biopsies in patients with ongoing suspicion of pleural malignancy despite a negative CT-guided biopsy. This was built on the premise that malignant pleural mesothelioma (MPM) in particular proves diagnostically challenging given its radiological appearance and the degree of overlap with benign pleural thickening [67]. Surprising to most pleural physicians and radiologists, their primary outcome of pleural malignancy correctly identified on 2 nd biopsy was not met (presented at BTS Winter 2019); however, the trial is still pending full publication and there is certainly more to learn from this.…”

Contemporary Approach to the Diagnosis of Malignant Pleural Effusion

“…The TARGET trial (ISRCTN14024829) has been designed to investigate the role of PET/CT in suspected MPE by assessing whether targeted biopsy based on 18 FDG avidity improves diagnostic sensitivity over conventional CT-guided biopsy with the potential secondary benefit of identifying distant metastatic disease. This trial also aims to further clarify the role of serum mesothelin by including this biomarker in the assessment of subjects with mesothelioma (65).…”

Current Applications for Nuclear Medicine Imaging in Pulmonary Disease

“…However, the study by Yildirim et al reported high sensitivity, specificity, and accuracy (88.2%, 92.9%, and 90.3%, respectively) for differentiation of malignant mesothelioma from asbestos-related benign pleural disease in a group of 31 patients [ 89 ] evaluated by PET/CT. Similarly, Sun et al reported high sensitivity of 93% for FDG PET/CT in differentiating malignant from benign pleural effusion [ 90 ].The recent TARGET trial explores the potential role of FDG PET/CT to target areas of high uptake when performing a CT-guided biopsy [ 91 ].…”