Published online before print October 30, 2003, 10.1148/radiol.2293021180
MR Angiography with Gadofosveset Trisodium for Peripheral Vascular Disease: Phase II Trial1
Pierre Perreault, MD,
Mark A. Edelman, MD,
Richard A. Baum, MD,
E. Kent Yucel, MD,
Robert M. Weisskoff, PhD,
Kohkan Shamsi, MMBS, MD, PhD and
Emile R. Mohler, III, MD
1 From Department of Radiology, CHUM-Hospital St Luc, Montreal, Quebec, Canada (P.P.); Department of Radiology, Rush North Shore Medical Center, Skokie, Ill (M.A.E.); Department of Radiology, Brigham and Women’s Hospital, Boston, Mass (R.A.B., E.K.Y.); EPIX Medical, Cambridge, Mass (R.M.W.); Berlex Laboratories, Montville, NJ (K.S.); and Cardiovascular Division, Department of Medicine, University of Pennsylvania School of Medicine, PHI Bldg, Rm 432, 51 N 39th St, Philadelphia, PA 19104 (E.R.M.). Received September 19, 2002; revision requested November 26; final revision received March 21, 2003; accepted April 14. Address correspondence to E.R.M. (e-mail: mohlere@uphs.upenn.edu).
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Figure 1. Representative gadofosveset-enhanced MR angiograms from the five dose groups plus placebo group.
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Figure 2a. ROC curves for gadofosveset-enhanced and nonenhanced MR angiographic detection of significant stenosis at 0.03 mmol/kg dose for readers (a) A, (b) B, and (c) C. For each reader, gadofosveset-enhanced MR angiography provided better diagnostic performance—that is, a higher sensitivity for a given false-positive rate—than did nonenhanced MR angiography.
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Figure 2b. ROC curves for gadofosveset-enhanced and nonenhanced MR angiographic detection of significant stenosis at 0.03 mmol/kg dose for readers (a) A, (b) B, and (c) C. For each reader, gadofosveset-enhanced MR angiography provided better diagnostic performance—that is, a higher sensitivity for a given false-positive rate—than did nonenhanced MR angiography.
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Figure 2c. ROC curves for gadofosveset-enhanced and nonenhanced MR angiographic detection of significant stenosis at 0.03 mmol/kg dose for readers (a) A, (b) B, and (c) C. For each reader, gadofosveset-enhanced MR angiography provided better diagnostic performance—that is, a higher sensitivity for a given false-positive rate—than did nonenhanced MR angiography.
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Figure 3. Graph shows dose response for increase in AUC of blinded MR angiography for three readers. All three readers demonstrated a significant improvement in interpretation (P < .001) with gadofosveset-enhanced MR angiographic images compared with that of nonenhanced MR angiographic images.
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Figure 4a. (a) Graph shows specificity of MR angiography with gadofosveset. Change in specificity was estimated on the basis of the difference between data obtained after and before gadofosveset administration. (b) Graph shows improvement in specificity. Specificity improved for all three readers for doses to and including 0.03 mmol/kg. When gadofosveset-enhanced MR angiography was compared with nonenhanced MR angiography, lowest dose (0.005 mmol/kg) had approximately the same specificity as nonenhanced MR angiography, and specificity increased to a 15%-32% improvement (across readers) at 0.03 mmol/kg.
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Figure 4b. (a) Graph shows specificity of MR angiography with gadofosveset. Change in specificity was estimated on the basis of the difference between data obtained after and before gadofosveset administration. (b) Graph shows improvement in specificity. Specificity improved for all three readers for doses to and including 0.03 mmol/kg. When gadofosveset-enhanced MR angiography was compared with nonenhanced MR angiography, lowest dose (0.005 mmol/kg) had approximately the same specificity as nonenhanced MR angiography, and specificity increased to a 15%-32% improvement (across readers) at 0.03 mmol/kg.
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Figure 5a. (a) Graph shows sensitivity of gadofosveset-enhanced MR angiography compared with that of nonenhanced MR angiography. (b) Graph shows improvement in sensitivity of gadofosveset-enhanced MR angiography compared with that of nonenhanced MR angiography. The 0.005 mmol/kg dose group for gadofosveset-enhanced MR angiography showed approximately the same sensitivity as nonenhanced MR angiography, and sensitivity increased at higher doses.
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Figure 5b. (a) Graph shows sensitivity of gadofosveset-enhanced MR angiography compared with that of nonenhanced MR angiography. (b) Graph shows improvement in sensitivity of gadofosveset-enhanced MR angiography compared with that of nonenhanced MR angiography. The 0.005 mmol/kg dose group for gadofosveset-enhanced MR angiography showed approximately the same sensitivity as nonenhanced MR angiography, and sensitivity increased at higher doses.
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Figure 6. Graph shows percentage of uninterpretable images after gadofosveset administration. For the postcontrast MR angiographic images, none of the images obtained with placebo were interpretable. At 0.01 mmol/kg dose, 5%-12% of the images were uninterpretable. At 0.03 mmol/kg dose and higher, nearly all (>97.4%) images were interpretable. Double line represents average percentage of uninterpretable images obtained with nonenhanced MR angiography, averaged across all readers and dose groups.
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Copyright © 2003 by the Radiological Society of North America.
