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  • Title: MR venography using an intravascular contrast agent: results from a multicenter phase 2 study of dosage.
    Author: Larsson EM, Sundén P, Olsson CG, Debatin J, Duerinckx AJ, Baum R, Hahn D, Ebner F.
    Journal: AJR Am J Roentgenol; 2003 Jan; 180(1):227-32. PubMed ID: 12490510.
    Abstract:
    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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