Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane.
| Autor: | Chin BB; Department of Radiology, Duke University Medical Center, Durham, North Carolina., Kronauge JF, Femia FJ, Chen J, Maresca KP, Hillier S, Petry NA, James OG, Oldan JD, Armor T, Stubbs JB, Stabin MG, Babich JW |
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| Jazyk: | angličtina |
| Zdroj: | Journal of nuclear medicine : official publication, Society of Nuclear Medicine [J Nucl Med] 2014 May; Vol. 55 (5), pp. 765-71. Date of Electronic Publication: 2014 Mar 13. |
| DOI: | 10.2967/jnumed.113.124057 |
| Abstrakt: | 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. |
| Databáze: | MEDLINE |
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