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DOI: 10.1148/radiol.2282012061
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(Radiology 2003;228:457-464.)
© RSNA, 2003

Gastrointestinal Imaging

Hepatic MR Imaging with Ferumoxides: Multicenter Study of Safety and Effectiveness of Direct Injection Protocol1

David A. Bluemke, MD, PhD, Therese M. Weber, MD, Daniel Rubin, MD, Eduard E. de Lange, MD, Richard Semelka, MD, Richard D. Redvanly, MD, Judith Chezmar, MD, Eric Outwater, MD, Ruth Carlos, MD, Sanjay Saini, MD, George A. Holland, MD2, Joseph F. Mammone, MD, PhD, Jeffrey J. Brown, MD, Bart Milestone, MD, Marcia C. Javitt, MD and Paula Jacobs, PhD

1 From Johns Hopkins Univ School of Med, 600 N Wolfe St, Baltimore, MD 21287 (D.A.B.); Univ of Alabama at Birmingham (T.M.W.); Good Samaritan Hosp, San Jose, Calif (D.R.); Univ of Virginia Health Sciences System, Charlottesville (E.E.d.L.); Scatliff MRI, UNC Hosp, Chapel Hill (R.S.); Emory Univ Hosp, Atlanta, Ga (R.D.R., J.C.); Thomas Jefferson Univ Hosp, Philadelphia, Pa (E.O.); Univ of Michigan, Ann Arbor (R.C.); Massachusetts Gen Hosp, Boston (S.S.); Med Coll of Pennsylvania-Tenet, Philadelphia (G.A.H.); Cooper Hosp/Univ Med Ctr, Camden, NJ (J.F.M.); Mallinckrodt Inst of Radiology, Washington Univ School of Med, St Louis, Mo (J.J.B.); Temple Univ Hosp, Philadelphia, Pa (B.M.); George Washington Univ Med Ctr, Washington, DC (M.C.J.); and Advanced Magnetics, Cambridge, Mass (P.J.). Received Dec 18, 2001; revision requested Feb 26, 2002; final revision received Oct 29; accepted Nov 27. Supported by Advanced Magnetics. Address correspondence to D.A.B. (e-mail: dbluemke@jhmi.edu).

PURPOSE: To compare the safety and effectiveness of an undiluted direct injection of ferumoxides with those of a diluted slow infusion of ferumoxides during 30 minutes in patients with known liver lesions or in those suspected of having them.

MATERIALS AND METHODS: Two hundred thirty-three patients at 16 institutions were randomized to receive either an undiluted direct injection of 0.56 mg of iron per kilogram of body weight of ferumoxides administered during 2 minutes (2 mL/min) or a diluted slow infusion administered during 30 minutes. Safety was assessed with monitoring for adverse events and laboratory tests. For sensitivity, specificity, and accuracy analysis, two independent blinded observers identified and classified lesions as benign or malignant with precontrast images and with pre- and postcontrast images combined.

RESULTS: There was no statistically significant difference in adverse events in the group with direct injection compared with those in the group with infusion (21 [18%] of 114 patients vs 19 [17%] of 112 patients, respectively). No serious adverse events were observed. The most common adverse events in the group with direct injection versus the group with infusion were headache (five [4%] of 114 vs three [3%] of 112, respectively) and back pain (five [4%] of 114 vs three [3%] of 112, respectively). Overall, in 68 (62%) of 109 patients with direct injection and 71 (66%) of 108 patients with infusion, additional magnetic resonance (MR) imaging information was obtained after ferumoxides administration (P = .67). Sensitivity, specificity, and accuracy for the diagnosis of malignancy were significantly improved by adding images obtained after ferumoxides administration to the images obtained before contrast agent administration (P < .05 for all comparisons).

CONCLUSION: Direct injection of ferumoxides has safety and effectiveness profiles similar to those of slow infusion of the agent. Further findings indicate that the addition of ferumoxides increases the sensitivity and specificity of hepatic MR evaluation when compared with unenhanced MR imaging.

© RSNA, 2003

Index terms: Contrast media • Iron • Liver neoplasms, diagnosis, 76.31, 76.32 • Liver neoplasms, MR, 76.121411, 76.12143




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