[Translation] An international, multicenter, phase III study comparing the diagnostic accuracy of 99mTc-EC-DG SPECT/CT and 18F-FDG PET/CT for the diagnosis and staging of patients with clinical and imaging (CT) evidence that meets the diagnostic criteria for lung cancer
1. 证明在肺癌高发的患者中,当参照真值标准对原发性和转移性病灶的图像判读进行比较时,SPECT/CT(99mTc-EC-DG)的敏感性或特异性指标非劣于 PET/CT(18F-FDG)。
2. 进一步证明 99mTc-EC-DG 在患者中的安全性。
[Translation] 1. To demonstrate that in patients with a high incidence of lung cancer, when comparing the image interpretation of primary and metastatic lesions with reference to true standard, the sensitivity or specificity of SPECT/CT (99mTc-EC-DG) is non-inferior to PET/CT (18F-FDG).
2. To further demonstrate the safety of 99mTc-EC-DG in patients.