[Translation] A randomized, open, crossover, multicenter, non-inferiority phase III clinical study to evaluate the diagnostic efficacy of 18F fluoro[18F] alpha-peptide PET-CT versus 18F fluorodeoxyglucose PET-CT in non-small cell lung cancer lymph node metastasis
主要目的:
与氟[18F]脱氧葡糖PET-CT相比,评价氟[18F]阿法肽PET-CT用于诊断非小细胞肺癌淋巴结转移的灵敏度与特异性。
次要目的:
与氟[18F]脱氧葡糖PET-CT相比,评价氟[18F]阿法肽PET-CT用于诊断非小细胞肺癌淋巴结转移的准确性、阳性预测值、阴性预测值;
与氟[18F]脱氧葡糖PET-CT相比,评价氟[18F]阿法肽PET-CT在非小细胞肺癌的安全性特征。
探索性目的:
比较氟[18F]阿法肽PET-CT与氟[18F]脱氧葡糖PET-CT相比诊断非小细胞肺癌淋巴结转移的一致性;
整合素αvβ3表达情况(可选)。
[Translation] Primary objective:
Compared with 18F-FDG PET-CT, evaluate the sensitivity and specificity of 18F-FDG PET-CT in diagnosing lymph node metastasis of non-small cell lung cancer.
Secondary objective:
Compared with 18F-FDG PET-CT, evaluate the accuracy, positive predictive value, and negative predictive value of 18F-FDG PET-CT in diagnosing lymph node metastasis of non-small cell lung cancer;
Compared with 18F-FDG PET-CT, evaluate the safety characteristics of 18F-FDG PET-CT in non-small cell lung cancer.
Exploratory objective:
Compared with 18F-FDG PET-CT, compare the consistency of 18F-FDG PET-CT in diagnosing lymph node metastasis of non-small cell lung cancer;
Expression of integrin αvβ3 (optional).