PT  - JOURNAL ARTICLE
AU  - Chin, Bennett
AU  - Grasfeder, Linda
AU  - Chen, Jianqing
AU  - Femia, Frank
AU  - Luss, Ed
AU  - Barrett, John
AU  - Petry, Neil
AU  - Greer, Kim
AU  - Babich, John
AU  - Kronauge, James
TI  - Formulation and human distribution comparison of AdreView and Ultratrace Iobenguane I 123
DP  - 2011 May 01
TA  - Journal of Nuclear Medicine
PG  - 1445--1445
VI  - 52
IP  - supplement 1
4099  - http://jnm.snmjournals.org/content/52/supplement_1/1445.short
4100  - http://jnm.snmjournals.org/content/52/supplement_1/1445.full
SO  - J Nucl Med2011 May 01; 52
AB  - 1445 Objectives Commercially available Iobenguane I 123 (AdreView) is produced using a halogen exchange reaction from stable iobenguane. A unique and alternative method to produce very high specific activity Iobenguane I 123 (Ultratrace) utilizes a solid state precursor procedure adapted from Ultratrace Iobenguane I 131. Iobenguane I 123 produced by both processes was studied in a human cross-over distribution imaging study in normal healthy volunteers. Methods Ultratrace was delivered to the clinical site, and AdreView was purchased from GE Healthcare. Both were assessed for purity and chemical content using a single quadrapole LC/MS assay. Six healthy subjects (4M, 2F) received 10 mCi in a crossover design imaging study with 1-2 weeks between doses. Heart/mediastinal ratios (H/M) were also measured. Results LC/MS analysis is summarized in the below table. Ultratrace specific activity was almost 1000 times higher than AdreView with lower concentration of degradation products that also bind NET receptors. Interim imaging results showed similar normal organ distribution and dosimetry between formulations. The delayed H/M were 2.1 ± 0.07 and 1.9 ± 0.04 for Ultratrace and AdreView, respectively (p=0.007). Conclusions AdreView and Ultratrace iobenguane I123 final drug product formulations demonstrate dramatic concentration differences in API related substances and specific activities. Imaging studies show similar normal organ distribution, excretion and tissue radiation dosimetry. Research Support NIH SBIR R44 CA 13039*meta-hydroxybenzylguanidine, ** benzyl guanidine, ***mean ± SD, n = 4. ****mean ± SD, n = 3.