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MR Venography Using an Intravascular Contrast Agent: Results from a Multicenter Phase 2 Study of Dosage

¹ Department of Neuroradiology, Center for Medical Imaging and Physiology, Lund University Hospital, SE-221 85, Lund, Sweden.
² Department of Internal Medicine, Lund University Hospital, SE-221 85, Lund, Sweden.
³ Department of Diagnostic Radiology, University Hospital Essen, Hufelandstr. 55, DE-45122 Essen, Germany.
⁴ Radiology Service, VA North Texas Healthcare System, 4500 S. Lancaster Rd., Dallas, TX 75216.
⁵ Department of Radiology, The Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115.
⁶ Institut für Röntgendiagnostik, Universität Würzburg, DE-97080 Würzburg, Germany.
⁷ MR-Institute, University Hospital Graz, Auenbruggerplatz 9, AT-8036 GRAZ, Austria.

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.

SUBJECTS AND 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.

CONCLUSION. 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.

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