Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane.

Published

Journal Article

UNLABELLED: A first-in-human phase 1 clinical study was performed on 12 healthy adults with a high-specific-activity carrier-free formulation of (123)I-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 (123)I-iobenguane showed organ distribution and whole-body retention similar to those of conventional (123)I-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 (123)I-iobenguane.

Full Text

Duke Authors

Cited Authors

  • Chin, BB; Kronauge, JF; Femia, FJ; Chen, J; Maresca, KP; Hillier, S; Petry, NA; James, OG; Oldan, JD; Armor, T; Stubbs, JB; Stabin, MG; Babich, JW

Published Date

  • May 2014

Published In

Volume / Issue

  • 55 / 5

Start / End Page

  • 765 - 771

PubMed ID

  • 24627436

Pubmed Central ID

  • 24627436

Electronic International Standard Serial Number (EISSN)

  • 1535-5667

Digital Object Identifier (DOI)

  • 10.2967/jnumed.113.124057

Language

  • eng

Conference Location

  • United States