The DOI matches its Crossref record; 25 of the 25 references it cites were found in a registry or an index.
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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Iron oxide nanoparticles: Diagnostic, therapeutic and theranostic applications
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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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