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Preclinical Safety and Pharmacokinetic Profile of Ferumoxtran-10, an Ultrasmall Superparamagnetic Iron Oxide Magnetic Resonance Contrast Agent
Abstract
OBJECTIVES: This report presents an overview of preclinical data available on ferumoxtran-10, an ultrasmall superparamagnetic iron oxide nanoparticular contrast agent proposed for lymph node magnetic resonance imaging. MATERIALS AND METHODS: Pharmacokinetic, safety pharmacology, single- and repeat-dose toxicity, reproduction toxicity, and genotoxicity studies were performed with ferumoxtran-10 given intravenously (bolus injection) in mice, rats, rabbits, dogs, and monkeys. RESULTS: Ferumoxtran-10 was taken up by macrophages, mostly in liver, spleen, and lymph nodes, within 24 hours after bolus injection and underwent progressive metabolism. Toxicity was observed only at very high exposure levels and mainly was linked to a massive iron load after repeated injections. Ferumoxtran-10 was not mutagenic but was teratogenic in rats and rabbits. DISCUSSION: The preclinical pharmacokinetic and safety profile of ferumoxtran-10 appears to be satisfactory in view of its proposed use as a single-dose diagnostic agent in human for MR imaging of lymph nodes.
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Cites
Noninvasive detection of clinically occult lymph-node metastases in prostate cancer
Harisinghani, M. G., Barentsz, J., Hahn, P. F., Deserno, W. M., Tabatabaei, S., van de Kaa, C. H., de la Rosette, J., & Weissleder, R. (2003) · New England Journal of Medicine · doi:10.1056/nejmoa022749 · Cited by 1,971
Kooi, M. E., Cappendijk, V. C., Cleutjens, K. B. J. M., Kessels, A. G. H., Kitslaar, P. J. E. H. M., Borgers, M., Frederik, P. M., Daemen, M. J. A. P., & van Engelshoven, J. M. A. (2003) · Circulation · doi:10.1161/01.cir.0000068315.98705.cc · Cited by 798
Cited by
Nanomaterials and nanoparticles: Sources and toxicity
Buzea, C., Pacheco, I. I., & Robbie, K. (2007) · Biointerphases · doi:10.1116/1.2815690 · Cited by 3,789
Longmire, M., Choyke, P. L., & Kobayashi, H. (2008) · Nanomedicine · doi:10.2217/17435889.3.5.703 · Cited by 2,149
Reddy, L. H., Arias, J. L., Nicolas, J., & Couvreur, P. (2012) · Chemical Reviews · doi:10.1021/cr300068p · Cited by 2,010
Superparamagnetic iron oxide nanoparticles: magnetic nanoplatforms as drug carriers
Wahajuddin, & Arora (2012) · International Journal of Nanomedicine · doi:10.2147/ijn.s30320 · Cited by 1,117
Lee, N., & Hyeon, T. (2012) · Chem. Soc. Rev. · doi:10.1039/c1cs15248c · Cited by 995
Metadata
- Authors
- Bourrinet, P., Bengele, H. H., Bonnemain, B., Dencausse, A., Idee, J.-M., Jacobs, P. M., & Lewis, J. M.
- Venue
- Investigative Radiology
- Published
- 2006-03
- Volume
- 41
- Issue
- 3
- Pages
- 313-324
- ISSN
- 0020-9996 (ISSN-L)
- OpenAlex
- W1972344593
- Cited by
- 339
- References
- 2
- FWCI
- 13.16
- Type
- journal article
- Language
- en
- Open access
- closed
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- The paper
- Bourrinet, P., Bengele, H. H., Bonnemain, B., Dencausse, A., Idee, J.-M., Jacobs, P. M., & Lewis, J. M. (2006). Preclinical Safety and Pharmacokinetic Profile of Ferumoxtran-10, an Ultrasmall Superparamagnetic Iron Oxide Magnetic Resonance Contrast Agent. Investigative Radiology. https://doi.org/10.1097/01.rli.0000197669.80475.dd
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