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, all only observed in a small subset of individuals.
“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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- 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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