MR venography using an intravascular contrast agent: results from a multicenter phase 2 study of dosage.
OBJECTIVE
The objective of this study was to determine the optimal dose of the iron oxide contrast agent feruglose for contrast-enhanced MR venography of the abdominopelvic and lower extremity veins and to evaluate its safety and tolerability in patients with deep venous thrombosis.


METHODS
We enrolled in our study a total of 45 patients at six centers who had lower extremity deep venous thrombosis documented on radiographic venography. Forty-four patients received the study drug; 39 completed the study. Each patient received three sequential IV injections of feruglose at doses of 0.75, 1.25, and 3.0 mg Fe/kg body weight. MR venography at 1.5 T was repeated at three levels after each dose. Safety was evaluated.


RESULTS
The agreement between contrast-enhanced MR venography and radiographic venography with regard to deep venous thrombosis above the knee was zero at the lowest dose (0.75 mg Fe/kg body weight), 43% at the dose 2.0 mg Fe/kg body weight, and 49% at the dose 5.0 mg Fe/kg body weight. No significant difference was seen between the two highest doses. The highest cumulative dose provided the greatest diagnostic usefulness score. No serious adverse events occurred.


CONCLUSIONS
The two highest doses of feruglose showed the best agreement between contrast-enhanced MR venography and radiographic venography for deep venous thrombosis above the knee. The safety and tolerability of feruglose were confirmed.
Larsson
Elna-Marie
EM
Department of Neuroradiology, Center for Medical Imaging and Physiology, Lund University Hospital, SE-221 85 Lund, Sweden.
Sundén
Paul
P
Olsson
Carl-Gustav
CG
Debatin
Jörg
J
Duerinckx
Andre J
AJ
Baum
Richard
R
Hahn
Dietbert
D
Ebner
Franz
F
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000008:administration & dosage* / Q000009:adverse effects; D003911:Dextrans; D005260:Female; D052203:Ferrosoferric Oxide; D006801:Humans; D007275:Injections, Intravenous; D007501:Iron / Q000008:administration & dosage* / Q000009:adverse effects; D007866:Leg / Q000098:blood supply*; D018810:Magnetic Resonance Angiography; D058185:Magnetite Nanoparticles; D008297:Male; D008875:Middle Aged; D010087:Oxides / Q000008:administration & dosage* / Q000009:adverse effects; D010690:Phlebography; D012680:Sensitivity and Specificity; D014680:Veins / Q000473:pathology*; D020246:Venous Thrombosis / Q000175:diagnosis* / Q000000981:diagnostic imaging
D003287:Contrast Media; D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; C097921:ferumoxtran-10; D007501:Iron; D052203:Ferrosoferric Oxide