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AJNR - American Journal of Neuroradiology

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American Journal of Neuroradiology 23:649-656, April 2002
© 2002 American Society of Neuroradiology

HEAD AND NECK

Ferumoxtran-10, A Superparamagnetic Iron Oxide as a Magnetic Resonance Enhancement Agent for Imaging Lymph Nodes: A Phase 2 Dose Study

Patricia A Hudgins^a, Yoshimi Anzai^b, Marie R Morris^c and Maria A Lucas^c

^a Department of Radiology, Emory University School of Medicine, Atlanta, GA
^b Department of Radiology, the University of Washington, School of Medicine, Seattle
^c Department of Radiology, Advanced Magnetics, Inc, Cambridge, MA

Address reprint requests to Patricia A. Hudgins, Department of Radiology, Emory University Hospital, 1364 Clifton Rd. NE, Atlanta, GA 30322

BACKGROUND AND PURPOSE: Dextran-coated ultrasmall superparamagnetic iron oxide ferumoxtran-10 (Combidex) is used in reticuloendothelial MR imaging. Our purpose was to determine the optimal dose and imaging time for lymph node evaluation.

MATERIALS: Twenty-four healthy volunteers underwent neck MR imaging before and 6, 12, 24, and 36 hours after receiving 1.1, 1.7, 2.6, or 3.4 mg Fe/kg ferumoxtran-10. Vital signs, serum and urine levels, and adverse events were monitored. Qualitative nodal architecture, size, and signal-intensity changes were assessed on T1-, T2-, and T2*-weighted (fast field-echo 25° or 80° flip angle [FFE-25 or FFE-80]) images. Region-of-interest intensities were measured quantitatively.

RESULTS: Consistently strong enhancement in normal nodes was found with 24- and 36-hour T2- and T2*-weighted imaging after 2.6 and 3.4 mg Fe/kg doses. No serious adverse events occurred. With 2.6 mg Fe/kg, unblinded (vs blinded) specificities at 24 and 36 hours, respectively, were 100% and 100% (vs 88% and 88%) with T2-weighted, 96% and 96% (vs 73% and 85%) with FFE-25, and 100% and 92% (vs 85% and 88%) with FFE-80 sequences. With 3.4 mg Fe/kg, unblinded (vs blinded) specificities at 24 and 36 hours, respectively, were 89% and 79% (vs 75% and 75%) with T2-weighted, 84% and 79% (vs 95% and 100%) with FFE-25, and 95% and 79% (vs 95% and 80%) with FFE-80 sequences.

CONCLUSION: Ferumoxtran-10 nodal imaging appears to be effective and safe. Signal intensity and specificity for normal nodes were best 24 or 36 hours after 2.6 and 3.4 mg Fe/kg doses. Nodal conspicuity was best with T2- and T2*-weighted sequences.

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