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一项评价99mTc-3PRGD2用于肺部肿瘤淋巴结转移诊断的有效性和安全性的多中心、开放、自身对照的临床研究
[Translation] A multicenter, open-label, self-controlled clinical study evaluating the efficacy and safety of 99mTc-3PRGD2 for the diagnosis of lymph node metastases in lung tumors
主要目的:评价锝[99mTc]肼基烟酰胺聚乙二醇双环 RGD 肽(99mTc-3PRGD2)用于肺部肿瘤淋巴结转移诊断的有效性。 次要目的:评价 99mTc-3PRGD2 用于肺部肿瘤良恶鉴别诊断的有效性;评价 99mTc-3PRGD2 在人体内的安全性。
[Translation] Main purpose: To evaluate the effectiveness of technetium [99mTc] hydrazine nicotinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2) in the diagnosis of lymph node metastasis in lung tumors. Secondary objectives: To evaluate the effectiveness of 99mTc-3PRGD2 in the differential diagnosis of benign and malignant lung tumors; to evaluate the safety of 99mTc-3PRGD2 in humans.
锝[99mTc]肼基烟酰胺聚乙二醇双环RGD 肽注射液在健康志愿者体内的药代动力学和安全性的I 期临床研究
[Translation] Phase I clinical study on the pharmacokinetics and safety of technetium[99mTc]hydrazinonicotinamide polyethylene glycol bicyclic RGD peptide injection in healthy volunteers
检测锝[99mTc]肼基烟酰胺聚乙二醇双环RGD 肽(99mTc-3PRGD2)注射液在健康志愿者体内的药代动力学,以及在人体内的生物分布及估算内照射辐射吸收剂量,为II期临床研究方案设计提供依据;观察99mTc-3PRGD2对健康志愿者的安全性。
[Translation] To detect the pharmacokinetics of technetium [99mTc] hydrazine nicotinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2) injection in healthy volunteers, as well as its biodistribution in human body and estimate the absorbed dose of internal radiation, as Provide the basis for the design of phase II clinical study program; observe the safety of 99mTc-3PRGD2 on healthy volunteers.
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