Comparison of the detection performance of [18F]FDG PET/CT with CT on bone metastases: randomized controlled clinical trial

Background Bone biopsy is the gold standard for diagnosing bone metastases. However, there is no clinical consensus regarding the optimal imaging test for locating the puncture site. Methods We compared the performance of [ ¹⁸ F]FDG PET/CT with CT in detecting bone metastases to achieve the highest biopsy efficiency. This registered prospective study enrolled 273 patients with bone lesions who were treated between January 2020 and March 2021. Patients were randomly assigned to undergo [ ¹⁸ F]FDG PET/CT or CT to locate the puncture site before bone biopsy. The accuracy, sensitivity, specificity, second biopsy rate, diagnostic time and cost-effectiveness of the two imaging tests were compared. Results The accuracy and sensitivity of [ ¹⁸ F]FDG PET/CT group in the diagnosis of bone metastases were significantly higher than CT group(97.08% vs. 90.44%, 98.76% vs. 92.22%, P <0.05). The second biopsy rate was significantly lower in the PET/CT group (2.19% vs. 5.15%; P  < 0.05). The diagnostic time of PET/CT was 18.33 ± 2.08 days, which was significantly shorter than 21.28 ± 1.25 days in CT group ( P < 0.05). The cost of [18F] FDG PETCT is 11428.35 yuan, and the cost of CT is 13287.52 yuan; the incremental cost is 1859.17 yuan. SUVmax > 6.3 combined with ALP > 103 U/L showed a tendency for tumor metastases with an AUC of 0.901 (95%CI 0.839 to 0.946, P<0.001). Conclusion [ ¹⁸ F]FDG PET/CT is more effective and less costly than CT in locating optimal bone biopsy site. Thus, [ ¹⁸ F]FDG PET/CT should be considered the optimal imaging test for locating the optimal puncture site for bone biopsy. Trial registration The prospective study was registered on 20180410, and the registration number is ChiCTR1800015540.