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在研机构- |
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在研适应症- |
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最高研发阶段无进展 |
首次获批国家/地区- |
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An Evaluation of the Efficacy and Safety of Technetium [99mTc] Hydrazinonicotinamide PEGylated Bicyclic RGD Peptide Injection in a Multicenter, Open, Self-controlled Clinical Trial for the Lymph Node Metastasis in Lung Tumors
The study drug Technetium [99mTc] Hydrazinonicotinamide PEGylated Bicyclic RGD Peptide Injection(99mTc-3PRGD2) of this study is a novel radioactive diagnostic preparation for clinical use as a nuclear medicine molecular probe for tumor SPECT/CT imaging.
After 99mTc-3PRGD2 is injected into the body, it is specifically taken up by integrin receptor-positive tumor tissue, and the image of tumor tissue can be obtained by SPECT/CT, This can be used for molecular imaging diagnosis and individualized treatment of common tumors.
The primary objective of this study was to evaluate the efficacy of 99mTc-3PRGD2 for the diagnosis of lymph node metastasis in lung tumors. The minor objective was to evaluate the efficacy of 99mTc-3PRGD2 in the differential diagnosis of benign and malignant lung tumors and the safety of 99mTc-3PRGD2 in vivo of humans.
Phase I Open Label Trial of Pharmacokinetics and Safety of 99mTc Niacinamide Polyethylene Glycol Bicyclic RGD Peptide (99mTc-3PRGD2) Injection in Healthy Volunteers
The study drug 99mTc-3PRGD2 of this study is a new radioactive diagnostic preparation for clinical use as a nuclear medicine molecular probe for tumor SPECT/CT imaging.
After 99mTc-3PRGD2 is injected into the body, it is specifically taken up by integrin receptor-positive tumor tissue, and tumor tissue is developed by SPECT/CT, which can be used for molecular imaging diagnosis and individualized treatment of common tumors.
The primary objectives of this study is to examine the pharmacokinetics the safety of 99mTc-3PRGD2 injection in healthy volunteers, as well as the biodistribution in the human body and to estimate the dose of internal radiation absorbed. This study provides the basis for the design of phase II clinical research programs.
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