Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane.
Journal Article (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
Electronic International Standard Serial Number (EISSN)
- 1535-5667
Digital Object Identifier (DOI)
- 10.2967/jnumed.113.124057
Language
- eng
Conference Location
- United States