Low-dose versus standard-dose computed tomography-guided core needle biopsy for lung nodules: a randomized controlled trial

Abstract Background: To assess relative safety and diagnostic performance for low- and standard-dose computed tomography (CT)-guided core needle biopsy (CNB) for lung nodules (LNs). Materials and Methods: This is a prospective randomized controlled trial (RCT) from a single-center. From June 2020 to December 2020, consecutive patients with LNs were randomly assigned into low- or standard-dose groups. The primary outcome was diagnosis accuracy, while secondary outcomes encompassed technical success, diagnostic yield, operative time, radiation dose, and CNB-related complications. This RCT was listed within ClinicalTrials.gov (NCT04217655), registered 3 January 2020. Results: A total of 200 patients were randomly assigned to low-dose (n = 100) and standard-dose (n = 100) groups. All patients achieved technical success of CT-guided CNB and the definite final diagnoses. No significant difference was found for operative times (n = 0.231) between 2 groups. The mean dose-length product was markedly reduced within low-dose group in comparison to standard-dose group (34.6 ± 11.1 vs. 351.4 ± 107.4 mGy-cm, P < 0.001). Within low-dose group, the diagnostic yield, sensitivity, specificity, and diagnosis accuracy were 68%, 91.5%, 100%, and 94%, respectively. Within standard-dose group, the diagnostic yield, sensitivity, specificity, and diagnosis accuracy were 65%, 88.6%, 100%, and 92%, respectively. There were no significances in diagnostic yield (P = 0.653) and diagnostic accuracy (P = 0.579) between 2 groups. No significant differences within rates of pneumothorax (P = 0.836) and lung hemorrhage (P = 0.744) between 2 groups were observed. Conclusions: Compared with standard-dose CT-guided CNB for LNs, low-dose CT can significantly reduce radiation dose, while yield comparable safety and diagnostic accuracy.