Phase-1 Clinical Trial Results of High-Specific-Activity Carrier-Free I-123-Iobenguane

作者：Chin Bennett B^*; Kronauge James F; Femia Frank J; Chen Jianqing; Maresca Kevin P; Hillier Shawn; Petry Neil A; James Olga G; Oldan Jorge D; Armor Thomas; Stubbs James B; Stabin Michael G; Babich John W

来源：Journal of Nuclear Medicine, 2014, 55(5): 765-771.

DOI：10.2967/jnumed.113.124057

• iobenguane I-123
• MIBG
• human dosimetry
• high specific activity
• human distribution

A first-in-human phase 1 clinical study was performed on 12 healthy adults with a high-specific-activity carrier-free formulation of I-123-iobenguane. Clinical data are presented on the behavior of this receptor-targeting imaging agent. Methods: Whole-body and thoracic planar and SPECT imaging were performed over 48 h for calculation of tissue radiation dosimetry and for evaluation of clinical safety and efficacy. Results: A reference clinical imaging database acquired over time for healthy men and women injected with high-specific-activity I-123-iobenguane showed organ distribution and whole-body retention similar to those of conventional I-123-iobenguane. The heart-to-mediastinum ratios for the high-specific-activity formulation were statistically higher than for conventional formulations, and the predicted radiation dosimetry estimations for some organs varied significantly from those based on animal distributions. Conclusion: Human normal- organ kinetics, radiation dosimetry, clinical safety, and imaging efficacy provide compelling evidence for the use of high-specific-activity I-123-iobenguane.

• 出版日期2014-5