[New super-paramagnetic iron particles for MRI. Phase II study of malignant liver tumors].
The clinical tolerability and diagnostic value of Resovist as a new superparamagnetic iron oxide contrast medium was studied in 30 patients with malignant focal liver lesions (28 metastases, 2 HCC) within a phase II multicenter study. Magnetic resonance imaging (MRI) was performed at 1.0 Tesla with T1-weighted FLASH- and T2-weighted spin echo sequences before and following intravenous injection of Resovist at three different dose groups (4, 8 and 16 mumol Fe/kg). Liver signal intensity was significantly reduced on post-contrast images, while malignant focal liver lesions showed no signal changes. Resovist improved tumor liver contrast and lesion-conspicuity, especially for lesions smaller than 1 cm. The dose of 8 mumol Fe/kg was sufficient to achieve diagnostic tumor-liver contrast. Compared to images directly after injection, the number of detected lesions did not improve until 70 min later. There were no significant changes in vital signs (heart rate, blood pressure) or laboratory values until 72 h post-injection.
Daldrup
H E
HE
Institut für Klinische Radiologie, Universität Münster.
Reimer
P
P
Rummeny
E J
EJ
Tombach
B
B
Berns
T
T
Balzer
T
T
Schimpfky
C
C
Peters
P E
PE
D000328:Adult; D000368:Aged; D006528:Carcinoma, Hepatocellular / Q000175:diagnosis*; D003287:Contrast Media; D003911:Dextrans; D003937:Diagnosis, Differential; D004305:Dose-Response Relationship, Drug; D005260:Female; D052203:Ferrosoferric Oxide; D006801:Humans; D007275:Injections, Intravenous; D007501:Iron; D008099:Liver / Q000473:pathology; D008113:Liver Neoplasms / Q000175:diagnosis* / Q000556:secondary; D008279:Magnetic Resonance Imaging / Q000379:methods*; D058185:Magnetite Nanoparticles; D008297:Male; D008875:Middle Aged; D010087:Oxides
D003287:Contrast Media; D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; D007501:Iron; C065507:ferumoxides; D052203:Ferrosoferric Oxide
Neue superparamagnetische Eisenpartikel für die MRT. Phase-II-Studie bei malignen Lebertumoren.