Multi-centric clinical study of 99Tcm-ethylenedicysteine

Objective 99Tcm-ethylenedicysteine (EC) is a new radiopharmaceutical for renal dynamic imaging produced by Jiangsu Institute of Nuclear Medicine,China. The aim of this phase Ⅳ clinical trial was to evaluate the efficacy and safety of 99Tcm-EC in a large number of patients with various renal disorders. Methods Fourteen Chinese hospitals had participated in this multi-center clinical triM. The 99TcmEC kits from eleven production batches were used. Three hundred and twenty-eight patients were entered into the study. Patients were intravenously injected with 99Tcm-EC and a series of dynamic renal imaging was acquired in each patient. The quality of kits and images was analyzed. Possible adverse events were observed and recorded. Results All quality control parameters of the radiopharmaceutical kits were up to the standard requirement. The radiochemical purity of 99Tcm-EC in all production batches exceeded 90%. All functioning kidneys were clearly visualized and high-quality renograms were obtained in all 328 patients. No adverse events were recorded during or after the examination process. Conclusion 99Tcm-EC is a potentially useful radiopharmaceutical in dynamic renal functional studies. Key words: Cysteine desulfthydrase;  Technetium;  Clinical trials;  Multicenter studies