Contrast-enhanced MR imaging of liver and spleen: first experience in humans with a new superparamagnetic iron oxide.
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.
Hamm
B
B
Department of Radiology, Charité, Humboldt-Universität Berlin, Germany.
Staks
T
T
Taupitz
M
M
Maibauer
R
R
Speidel
A
A
Huppertz
A
A
Frenzel
T
T
Lawaczeck
R
R
Wolf
K J
KJ
Lange
L
L
D000328:Adult; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D003911:Dextrans; D004305:Dose-Response Relationship, Drug; D004361:Drug Tolerance; D052203:Ferrosoferric Oxide; D006801:Humans; D007089:Image Enhancement / Q000379:methods; D007275:Injections, Intravenous; D007501:Iron / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D008099:Liver / Q000033:anatomy & histology*; D008279:Magnetic Resonance Imaging / Q000379:methods; D058185:Magnetite Nanoparticles; D008297:Male; D010087:Oxides / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D010314:Partial Thromboplastin Time; D010919:Placebos; D011446:Prospective Studies; D016037:Single-Blind Method; D013154:Spleen / Q000033:anatomy & histology*; D013535:Suspensions
D003287:Contrast Media; D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; D010919:Placebos; D013535:Suspensions; D007501:Iron; C065507:ferumoxides; D052203:Ferrosoferric Oxide