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Contrast-enhanced MR imaging of liver and spleen: first experience in humans with a new superparamagnetic iron oxide
Abstract
The aim of this prospective study was to obtain the first human safety and magnetic resonance (MR) imaging results with a new formulation of superparamagnetic iron oxide (SPIO) (SHU 555 A). The SPIO was tested at four iron doses, from 5 to 40 mumol/kg. Laboratory tests and clinical measurements were done in 32 healthy volunteers for up to 3 weeks after administration. MR imaging at 1.5 T was performed before and 8 hours to 14 days after fast intravenous injection (500 mumol Fe/min) of the SPIO (six subjects per dose). Results of this phase I study demonstrate that SHU 555 A at a concentration of 0.5 mol Fe/L was well tolerated. A dose-dependent minor increase in activated partial thromboplastin time, which remained within the normal range, was seen. All doses of SPIO caused a signal loss in both liver and spleen (P < .05) with a spin-echo sequence (TR = 2,300 msec, TE = 45 msec). The signal losses in the liver 8 hours after contrast agent injection were 58%, 79%, 82%, and 87% for the 5, 10, 20, and 40 mumol Fe/kg doses, respectively. The corresponding signal losses in the spleen were 23%, 45%, 65%, and 78%, respectively. The doses that reduced signal intensity by half were 3.1 mumol Fe/kg for the liver and 12.8 mumol Fe/kg for the spleen. The results suggest that the new SPIO formulation is a safe and efficient MR contrast agent.
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“A clinical study assessing the toxicity of ferumcarbotran reported adverse effects such as irritation at the site of injection, pain and headache, which were all only observed in a small subset of individuals [134].”
From Iron oxide nanoparticles: Diagnostic, therapeutic and theranostic applications (2019) · cites this paper as [134]
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Mohtashamdolatshahi, A., Kratz, H., Kosch, O., Hauptmann, R., Stolzenburg, N., Wiekhorst, F., Sack, I., Hamm, B., Taupitz, M., & Schnorr, J. (2020) · Scientific Reports · doi:10.1038/s41598-020-74151-4 · Cited by 29
Heilmaier, C., Lutz, A. M., Bolog, N. V., Weishaupt, D., Seifert, B., & Willmann, J. K. (2009) · Radiology · doi:10.1148/radiol.2533090161 · Cited by 29
Abdollah, M. R. A., Kalber, T. L., Tolner, B., Southern, P., Bear, J. C., Robson, M. P., Pedley, R. B., Parkin, I. P., Pankhurst, Q. A., Mulholland, P. J., et al. (2014) · Faraday Discussions · doi:10.1039/c4fd00114a · Cited by 28
Iron particles enhance visualization of experimental gliomas with high-resolution sonography.
Nolte, I. S., Vince, G. H., Mäurer, M., Herbold, C., Goldbrunner, R., Solymosi, L., Stoll, G., & Bendszus, M. (2005) · PubMed Central · Cited by 27
Tanahashi, K., & Mikos, A. G. (2003) · Journal of Biomedical Materials Research Part A · doi:10.1002/jbm.a.10147 · Cited by 26
Ichihashi, S., Marugami, N., Tanaka, T., Iwakoshi, S., Kurumatani, N., Kitano, S., Nogi, A., & Kichikawa, K. (2013) · Journal of Vascular Surgery · doi:10.1016/j.jvs.2012.12.061 · Cited by 25
Contrast agents for MR imaging of the liver: a clinical overview
Mahfouz, A. E., Hamm, B., & Taupitz, M. (1997) · European Radiology · doi:10.1007/s003300050193 · Cited by 25
Contrast Media for X-ray and Magnetic Resonance Imaging
Frenzel, T., Lawaczeck, R., Taupitz, M., Jošt, G., Lohrke, J., Sieber, M. A., & Pietsch, H. (2015) · Investigative Radiology · doi:10.1097/rli.0000000000000193 · Cited by 24
In vitro labelling of mouse embryonic stem cells with SPIO nanoparticles.
Krejčí, J., Pachernı́k, J., Hampl, A., & Dvořák, P. (2008) · PubMed · Cited by 24
Immunological impact of magnetic nanoparticles (Ferucarbotran) on murine peritoneal macrophages
Yeh, C., Hsiao, J., Wang, J., & Sheu, F. (2009) · Journal of Nanoparticle Research · doi:10.1007/s11051-009-9589-y · Cited by 24
Ward, J., Baudouin, C. J., Ridgway, J. P., & RObinson, P. J. (1995) · British Journal of Radiology · doi:10.1259/0007-1285-68-809-463 · Cited by 24
Metadata
- Authors
- Hamm, B., Staks, T., Taupitz, M., Maibauer, R., Speidel, A., Huppertz, A., Frenzel, T., Lawaczeck, R., Wolf, K. J., & Lange, L.
- Affiliations
- Humboldt-Universität zu Berlin (DE)
- Freie Universität Berlin (DE)
- Corresponding author
- Hamm, Bernd
- Venue
- Journal of Magnetic Resonance Imaging
- Publisher
- Wiley
- Published
- 1994-09
- Volume
- 4
- Issue
- 5
- Pages
- 659-668
- ISSN
- 1053-1807 (ISSN-L)
- 1522-2586
- OpenAlex
- W2163391474
- Cited by
- 187
- References
- 25
- Citations by year
- 2024: 5 · 2023: 2 · 2022: 2 · 2021: 5 · 2020: 7 · 2019: 6 · 2018: 4 · 2017: 3 · 2016: 4 · 2015: 5 · 2014: 10 · 2013: 15 · 2012: 5
- FWCI
- 8.80
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Magnetic Resonance Imaging (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Advanced MRI Techniques and Applications
- Physical Sciences › Engineering › Biomedical Engineering › Characterization and Applications of Magnetic Nanoparticles
- Physical Sciences › Materials Science › Materials Chemistry › Lanthanide and Transition Metal Complexes
- Keywords
- superparamagnetic iron oxide nanoparticles, MRI contrast agents, liver imaging, spleen imaging, contrast-enhanced MRI, safety and tolerability, activated partial thromboplastin time
- MeSH terms
- Adult, Contrast Media, Dextrans, Dose-Response Relationship, Drug, Drug Tolerance, Humans, Image Enhancement, Injections, Intravenous, Iron, Liver, Magnetic Resonance Imaging, Male, Oxides, Partial Thromboplastin Time, Placebos, Prospective Studies, Spleen, Suspensions, Single-Blind Method, Ferrosoferric Oxide, Magnetite Nanoparticles
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