[Translation] A randomized, open-label, crossover, multicenter, non-inferiority phase III clinical trial evaluating the efficacy of fluoro[18F]alfatide PET-CT compared with fluoro[18F]deoxyglucose PET-CT in the diagnosis of lymph node metastases in non-small cell lung cancer Research
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] main purpose:
To evaluate the sensitivity and specificity of fluoro[18F]alphapeptide PET-CT for the diagnosis of lymph node metastases in non-small cell lung cancer compared with fluoro[18F]deoxyglucose PET-CT.
Secondary purpose:
To evaluate the accuracy, positive predictive value and negative predictive value of fluoro[18F]alpha peptide PET-CT in the diagnosis of lymph node metastasis in non-small cell lung cancer compared with fluoro[18F]deoxyglucose PET-CT;
To evaluate the safety profile of fluoro[18F]alphapeptide PET-CT in non-small cell lung cancer compared with fluoro[18F]deoxyglucose PET-CT.
Exploratory Purpose:
To compare the consistency of fluoro[18F]alpha peptide PET-CT and fluoro[18F]deoxyglucose PET-CT in the diagnosis of lymph node metastasis in non-small cell lung cancer;
Integrin αvβ3 expression (optional).