[Translation] A Phase I Clinical Trial to Evaluate the Safety, Radiation Dosimetry, and Pharmacokinetics of Technetium [99mTc] Isonitrile Glucosamine (99mTc-CNDG7) Injection as a SPECT Tracer in Chinese Healthy Subjects and Patients with Non-Small Cell Lung Cancer
主要目的:评价不同剂量下 99mTc-CNDG7 注射液在中国健康受试者和非小细胞肺癌(NSCLC)患者中的安全性和耐受性。
次要目的:
(1)评价 99mTc-CNDG7 注射液在中国健康受试者和 NSCLC 患者中的生物分布和辐射剂量学特征。
(2)评价 99mTc-CNDG7 注射液在中国健康受试者和 NSCLC 患者中的药代动力学特征和代谢稳定性。
(3)初步评价不同放射性给药剂量对 99mTc-CNDG7 注射液单光子发射计算机断层成像(SPECT)/CT 扫描的图像质量、肿瘤病灶的靶本比(TBR)的影响,为后期临床试验成像条件提供参考依据。
(4)评价 99mTc-CNDG7 注射液的使用对环境和医务人员的辐射安全性。
[Translation] Primary objective: To evaluate the safety and tolerability of 99mTc-CNDG7 injection at different doses in Chinese healthy subjects and patients with non-small cell lung cancer (NSCLC).
Secondary objectives:
(1) To evaluate the biodistribution and radiation dosimetry characteristics of 99mTc-CNDG7 injection in Chinese healthy subjects and patients with NSCLC.
(2) To evaluate the pharmacokinetic characteristics and metabolic stability of 99mTc-CNDG7 injection in Chinese healthy subjects and patients with NSCLC.
(3) To preliminarily evaluate the effects of different radioactive administration doses on the image quality of single photon emission computed tomography (SPECT)/CT scanning and the target-to-body ratio (TBR) of tumor lesions of 99mTc-CNDG7 injection, and to provide a reference for imaging conditions in later clinical trials.
(4) To evaluate the radiation safety of the use of 99mTc-CNDG7 injection on the environment and medical staff.