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Head and Neck Imaging |
1 From the Department of Radiology, Johns Hopkins University School of Medicine, 600 N Wolfe St, Baltimore, MD 21287 (D.A.B.); Department of Radiology, Cleveland Clinic, Ohio (A.E.S.); Department of Radiology, William Beaumont Hospital, Royal Oak, Mich (K.G.B.); Department of Radiology, University of Wisconsin, Madison (T.M.G.); Department of Radiology, Hospital of the University of Pennsylvania, Philadelphia (R.A.B.); Department of Radiology, Fletcher Allen Health Care, University of Vermont, Burlington (R.D.); Mallinckrodt Institute of Radiology, Washington University Medical Center, St Louis, Mo (E.S.M.); Mallinckrodt, St Louis, Mo (J.A.P.); and EPIX Medical, Cambridge, Mass (E.K.Y.). From the 1999 RSNA scientific assembly. Received May 19, 2000; revision requested July 12; revision received August 3; accepted September 12. D.A.B., A.E.S., K.G.B., T.M.G., R.A.B., R.D., and E.S.M. supported by grants from EPIX Medical and Mallinckrodt. Address correspondence to D.A.B. (e-mail: dbluemke@rad.jhu.edu).
PURPOSE: To evaluate the safety and efficacy of MS-325 in patients suspected of having carotid arterial disease.
MATERIALS AND METHODS: Fifty carotid arteries in 26 patients were imaged with three-dimensional spoiled gradient-recalled-echo magnetic resonance (MR) angiography at 5 and 50 minutes after injection of MS-325. MS-325 was administered intravenously as a single dose of 0.01, 0.03, or 0.05 mmol per kilogram of body weight as determined with a dose randomization scheme for four, nine, and 13 patients, respectively. Safety, including clinical laboratory changes and electrocardiographic monitoring, was assessed until approximately 3 days after injection. Conventional contrast agent–enhanced angiography was used as the standard of reference. Independent readers blinded to the dose interpreted the MR angiographic and conventional images. Images were assessed for location and extent of carotid arterial stenosis.
RESULTS: There were no severe or serious adverse events. For the determination of clinically significant stenosis (>70%) on the 5-minute images, sensitivity, specificity, and accuracy (P = .07, three-way comparison) were 100%, 100%, and 100%; 63%, 100%, and 88%; and 40%, 75%, and 55% at 0.01, 0.03, and 0.05 mmol/kg, respectively. Sensitivity and specificity for images at 50 minutes after MS-325 administration showed the same trends as the 5-minute images.
CONCLUSION: Overall accuracy for MS-325–enhanced carotid MR angiography performed during steady-state conditions of circulating contrast agent approximately 5 minutes after injection was high (88%–100%) at 0.03 and 0.01 mmol/kg. MS-325 was well tolerated at all evaluated doses.
Index terms: Carotid arteries, MR, 904.12942, 904.12943 • Carotid arteries, stenosis or obstruction, 904.721 • Contrast media, experimental studies, 904.12942, 904.12943 • Magnetic resonance (MR), contrast media, 904.12942, 904.12943 • Magnetic resonance (MR), vascular studies, 904.12942, 904.12943
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