Carotid MR angiography: Phase II study of safety and efficacy for MS-3251

D. A. Bluemke, A. E. Stillman, K. G. Bis, T. M. Grist, R. A. Baum, R. D'Agostino, E. S. Malden, J. A. Pierro, E. K. Yucel

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)114-122
Number of pages9
JournalRadiology
Volume219
Issue number1
StatePublished - 2001

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Magnetic Resonance Angiography
Safety
Contrast Media
Injections
Sensitivity and Specificity
Carotid Artery Diseases
Carotid Stenosis
Random Allocation
Carotid Arteries
gadofosveset trisodium
Angiography
Pathologic Constriction
Magnetic Resonance Spectroscopy
Body Weight

Keywords

  • Carotid arteries, MR
  • Carotid arteries, stenosis or obstruction
  • Contrast media, experimental studies
  • Magnetic resonance (MR), Contrast media
  • Magnetic resonance (MR), vascular studies

ASJC Scopus subject areas

  • Radiological and Ultrasound Technology

Cite this

Bluemke, D. A., Stillman, A. E., Bis, K. G., Grist, T. M., Baum, R. A., D'Agostino, R., ... Yucel, E. K. (2001). Carotid MR angiography: Phase II study of safety and efficacy for MS-3251. Radiology, 219(1), 114-122.

Carotid MR angiography : Phase II study of safety and efficacy for MS-3251. / Bluemke, D. A.; Stillman, A. E.; Bis, K. G.; Grist, T. M.; Baum, R. A.; D'Agostino, R.; Malden, E. S.; Pierro, J. A.; Yucel, E. K.

In: Radiology, Vol. 219, No. 1, 2001, p. 114-122.

Research output: Contribution to journalArticle

Bluemke, DA, Stillman, AE, Bis, KG, Grist, TM, Baum, RA, D'Agostino, R, Malden, ES, Pierro, JA & Yucel, EK 2001, 'Carotid MR angiography: Phase II study of safety and efficacy for MS-3251', Radiology, vol. 219, no. 1, pp. 114-122.
Bluemke DA, Stillman AE, Bis KG, Grist TM, Baum RA, D'Agostino R et al. Carotid MR angiography: Phase II study of safety and efficacy for MS-3251. Radiology. 2001;219(1):114-122.
Bluemke, D. A. ; Stillman, A. E. ; Bis, K. G. ; Grist, T. M. ; Baum, R. A. ; D'Agostino, R. ; Malden, E. S. ; Pierro, J. A. ; Yucel, E. K. / Carotid MR angiography : Phase II study of safety and efficacy for MS-3251. In: Radiology. 2001 ; Vol. 219, No. 1. pp. 114-122.
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abstract = "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.",
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T1 - Carotid MR angiography

T2 - Phase II study of safety and efficacy for MS-3251

AU - Bluemke, D. A.

AU - Stillman, A. E.

AU - Bis, K. G.

AU - Grist, T. M.

AU - Baum, R. A.

AU - D'Agostino, R.

AU - Malden, E. S.

AU - Pierro, J. A.

AU - Yucel, E. K.

PY - 2001

Y1 - 2001

N2 - 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.

AB - 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.

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KW - Carotid arteries, stenosis or obstruction

KW - Contrast media, experimental studies

KW - Magnetic resonance (MR), Contrast media

KW - Magnetic resonance (MR), vascular studies

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