PET-CT guided versus CT-guided biopsy in suspected malignant pleural thickening; a randomised trial.
De Fonseka D., Arnold DT., Smartt HJM., Culliford L., Stadon L., Tucker E., Morley A., Zahan-Evans N., Bibby AC., Lynch G., Mishra E., Khan S., Haris M., Steer H., Lewis L., Ionescu A., Harvey J., Blyth K., Rahman NM., Edey AE., Rogers CA., Maskell NA.
BackgroundPleural biopsy is the gold standard for diagnosis of pleural malignancy but a significant proportion will have a inconclusive biopsy despite ongoing clinical suspicion of malignancy. We investigated whether positron emission tomography computed tomography (PET-CT) targeted pleural biopsy is superior to standard CT-guided pleural biopsy following an initial non-diagnostic biopsy.MethodsThe TARGET trial was a multicentre parallel group randomised trial. Patients with a previous inconclusive pleural biopsy but an ongoing suspicion of pleural malignancy were randomised (1:1) to receive either CT-guided biopsy (standard care) or PET-CT followed by a targeted CT biopsy (intervention). The primary outcome was pleural malignancy correctly identified from the trial biopsy.ResultsBetween September 2015 and September 2018, 59 participants were randomised from 8 UK hospital sites, 29 to CT-only followed by targeted biopsy, and 30 to PET-CT followed by targeted biopsy. The proportion of pleural malignancy correctly identified was similar between the groups (risk ratio 1.03, 95%C.I. 0.83-1.29, p=0.77). The sensitivity of the trial biopsy to identify pleural malignancy was 79% (95%C.I. 54-94%) in the CT-only group versus 81% (95%C.I. 54-96%) in the PET-CT group.InterpretationThe results do not support the practice of PET-CT to guide pleural biopsies in patients with a previous non-diagnostic biopsy. The diagnostic sensitivity in the CT-only group was higher than anticipated and supports the practice of repeating a CT-guided biopsy following an inconclusive result if clinical suspicion of malignancy persists.