Diagnostic performance of gadobenate dimeglumine-enhanced MR angiography of the iliofemoral and calf arteries: A large-scale multicenter trial

American Journal of Roentgenology

Volumn 189, Issue 5, 2007, Pages 1223-1237

  Thurnher, Siegfried ^a   Miller, Stephan ^b   Schneider, Günther ^c   Ballarati, Claudio ^d   Bongartz, Georg ^e   Herborn, Christoph U ^f   Schoenberg, Stefan ^g   Cova, Maria Assunta ^h   Morana, Giovanni ⁱ   Niazi, Khusrow ^j   Iezzi, Roberto ^k   Taupitz, Matthias ^l   Bluemke, David A ^m   Kreitner, Karl Friedrich ⁿ   Kirchin, Miles A ^o   Pirovano, Gianpaolo ^p  

^a St John of God Hospital Vienna   (Austria)

^b UNIVERSITY OF TÜBINGEN   (Germany)

^c SAARLAND UNIVERSITY   (Germany)

^d VALDUCE HOSPITAL   (Italy)

^e UNIVERSITY HOSPITAL BASEL   (Switzerland)

^f UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^g LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^h UNIVERSITY OF TRIESTE   (Italy)

ⁱ OSPEDALE CA FONCELLO   (Italy)

^j EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^k UNIVERSITY OF CHIETI   (Italy)

^l CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^m JOHNS HOPKINS UNIVERSITY   (United States)

ⁿ JOHANNES GUTENBERG UNIVERSITY   (Germany)

^o Bracco Imaging SpA   (Italy)

^p Bracco Research USA   (United States)

more..

Author keywords

Contrast agents; Diagnostic performance; Gadobenate dimeglumine; MR angiography; Peripheral arterial occlusive disease

Indexed keywords

GADOBENATE DIMEGLUMINE;

ADULT; AGED; ARTERY OCCLUSION; ARTICLE; CLINICAL TRIAL; CONTRAST ENHANCEMENT; DIAGNOSTIC IMAGING; DIASTOLIC BLOOD PRESSURE; DIGITAL SUBTRACTION ANGIOGRAPHY; FEMALE; FEMORAL ARTERY; HUMAN; ILIAC ARTERY; IMAGE ANALYSIS; INJECTION SITE WARMTH; INTERMETHOD COMPARISON; MAGNETIC RESONANCE ANGIOGRAPHY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PERFORMANCE; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; REPRODUCIBILITY; SIDE EFFECT; SYSTOLIC BLOOD PRESSURE;

ADULT; AGED; ARTERIAL OCCLUSIVE DISEASES; CONTRAST MEDIA; EUROPE; FEMALE; HUMANS; IMAGE ENHANCEMENT; MAGNETIC RESONANCE ANGIOGRAPHY; MALE; MEGLUMINE; MIDDLE AGED; ORGANOMETALLIC COMPOUNDS; PERIPHERAL VASCULAR DISEASES; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SOUTH AMERICA; THIGH;

EID: 35649021275     PISSN: 0361803X     EISSN: None     Source Type: Journal    
DOI: 10.2214/AJR.07.2218     Document Type: Article

References (63)

1. Rofsky NM, Adelman MA. MR angiography in the evaluation of atherosclerotic peripheral vascular disease. Radiology 2000; 214:325-338
2. Hessel SJ, Adams DF, Abrams HL. Complications of angiography. Radiology 1981; 138:273-281
3. Catalano C, Fraioli F, Laghi A, et al. Infrarenal aortic and lower-extremity arterial disease: diagnostic performance of multi-detector row CT angiography. Radiology 2004; 231:555-563
4. Ota H, Takase K, Igarashi K, et al. MDCT compared with digital subtraction angiography for assessment of lower extremity arterial occlusive disease: importance of reviewing cross-sectional images. AJR 2004; 182:201-209
5. Willmann JK, Baumert B, Schertler T, et al. Aortoiliac and lower extremity arteries assessed with 16-detector row CT angiography: prospective comparison with digital subtraction angiography. Radiology 2005; 236:1083-1093
6. Schertler T, Wildermuth S, Alkadhi H, Kruppa M, Marincek B, Boehm T. Sixteen-detector row CT angiography for lower-leg arterial occlusive disease: analysis of section width. Radiology 2005; 237:649-656
7. Winterer JT, Laubenberger J, Scheffler K, et al. Contrast-enhanced subtraction MR angiography in occlusive disease of the pelvic and lower limb arteries: results of a prospective intraindividual comparative study with digital subtraction angiography in 76 patients. J Comput Assist Tomogr 1999; 23:583-589
8. Visser K, Hunmk MG. Peripheral arterial disease: gadolinium-enhanced MR angiography versus color-guided duplex US - a meta-analysis. Radiology 2000; 216:67-77
9. Nelemans PJ, Leiner T, de Vet HC, van Engelshoven JM. Peripheral arterial disease: meta-analysis of the diagnostic performance of MR angiography. Radiology 2000; 217:105-114
10. Kreitner KF, Kalden P, Neufang A, et al. Diabetes and peripheral arterial occlusive disease: prospective comparison of contrast-enhanced three-dimensional MR angiography with conventional digital subtraction angiography. AJR 2000; 174:171-179
11. Wang Y, Winchester PA, Khilnani NM, et al. Contrast-enhanced peripheral MR angiography from the abdominal aorta to the pedal arteries: combined dynamic two-dimensional and bolus-chase three-dimensional acquisitions. Invest Radiol 2001; 36:170-177
12. Bezooijen R, van den Bosch HC, Tielbeek AV, et al. Peripheral arterial disease: sensitivity-encoded multiposition MR angiography compared with intraarterial angiography and conventional multiposition MR angiography. Radiology 2004; 231:263-271
13. Vavrik J, Rohrmoser GM, Madani B, Ersek M, Tscholakoff D, Bucek RA. Comparison of MR angiography versus digital subtraction angiography as a basis for planning treatment of lower limb occlusive disease. J Endovasc Ther 2004; 11:294-301
14. Lapeyre M, Kobeiter H, Desgranges P, Rahmouni A, Becquemin JP, Luciani A. Assessment of critical limb ischemia in patients with diabetes: comparison of MR angiography and digital subtraction angiography. AJR 2005; 185:1641-1650
15. Leiner T. Magnetic resonance angiography of abdominal and lower extremity vasculature. Top Magn Reson Imaging 2005; 16:21-66
16. Pavlovic C, Futamatsu H, Angiolillo DJ, et al. Quantitative contrast-enhanced magnetic resonance imaging for the evaluation of peripheral arterial disease: a comparative study versus standard digital angiography. Int J Cardiovasc Imaging 2007; 23:225-232 [Epub ahead of print 2006 Jul 27]
17. Leiner T, de Vries M, Hoogeveen R, Vasbinder GB, Lemaire E, van Engelshoven JM. Contrast-enhanced peripheral MR angiography at 3.0 Tesla: initial experience with a whole-body scanner in healthy volunteers. J Magn Reson Imaging 2003; 17:609-614
18. Li W, Vu AT, Tutton S, et al. Scoutless stepping-table peripheral contrast-enhanced MR angiography. J Magn Reson Imaging 2006; 23:235-241
19. Madhuranthakam AJ, Hu HH, Kruger DG, Glockner JF, Riederer SJ. Contrast-enhanced MR angiography of the peripheral vasculature with a continuously moving table and modified elliptical centric acquisition. Radiology 2006; 240:222-229
20. Huegli RW, Aschwanden M, Scheffler K, Bilecen D. Fluoroscopic contrast-enhanced MR angiography with a magnetization-prepared steady-state free precession technique in peripheral arterial occlusive disease. AJR 2006; 187:242-247
21. Pintaske I, Martirosian P, Graf H, et al. Relaxivity of gadopentetate dimeglumine (Magnevist), gadobutrol (Gadovist), and gadobenate dimeglumine (MultiHance) in human blood plasma at 0.2, 1.5, and 3 Tesla. Invest Radiol 2006; 41:213-221. [Erratum in Invest Radiol 2006; 41:859]
22. de Haën C, Cabrini M, Akhnana L, Ratti D, Calabi L, Gozzini L. Gadobenate dimeglumine 0.5 M solution for injection (MultiHance) pharmaceutical formulation and physicochemical properties of a new magnetic resonance imaging contrast medium. J Comput Assist Tomogr 1999; 23[suppl 1]:S161-S168
23. Cavagna FM, Maggioni F, Castelli PM, et al. Gadolinium chelates with weak binding to serum proteins. Invest Radiol 1997; 32:780-796
24. Knopp MV, Schoenberg SO, Rehm C, et al. Assessment of gadobenate dimeglumine for magnetic resonance angiography: phase I studies. Invest Radiol 2002; 37:706-715
25. Pediconi F, Fraioli F, Catalano C, et al. Gadobenate dimeglumine (Gd-BOPTA) vs gadopentetate dimeglumine (Gd-DTPA) for contrast-enhanced magnetic resonance angiography (MRA): improvement in intravascular signal intensity and contrast to noise ratio. Radiol Med (Torino) 2003; 106:87-93
26. Prokop M, Schneider G, Vanzulli A, et al. Contrast-enhanced MR angiography of the renal arteries: blinded multicenter crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine. Radiology 2005; 234:399-408
27. Knopp MV, Giesel FL, von Tengg-Kobligk H, et al. Contrast-enhanced MR angiography of the run-off vasculature: intraindividual comparison of gadobenate dimeglumine with gadopentetate dimeglumine. J Magn Reson Imaging 2003; 17:694-702
28. Wyttenbach R, Gianella S, Alerci M, Braghetti A, Cozzi L, Gallino A. Prospective blinded evaluation of Gd-DOTA- versus Gd-BOPTA-enhanced peripheral MR angiography, as compared with digital subtraction angiography. Radiology 2003; 227:261-269
29. European Medicines Agency. Guidehne for Good Clinical Practice. CMPH/ICH/135/95, July 2002. Available at: www.emea.europa.eu/pdfs/human/ich/ 013595en.pdf. Accessed July 11, 2007
30. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects, revised. Edinburgh, Scotland: World Medical Assocation, 2000
31. Criteria Committee of the American Heart Association. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels, 9th ed. New York, NY: Little, Brown, 1994
32. Lipsitz SH, Kim K, Zhao L. Analysis of repeated categorical data using generalized estimating equations. Stat Med 1994; 13:1149-1163
33. Fontaine R, Kim M, Kieny R. Die chirurgische Behandlung der peripheren Durch-blutungsstörangen. Helv Chir Acta 1954; 21:499-533
34. Guidance for Industry. Developing medical imaging drug and biological products. Part 2, Clinical indications. June 2004. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) Website. Available at: www.fda.gov/cber/gdlns/medimageind.htm. Accessed July 13, 2007
35. The European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products (CPMP): Points to consider on the evaluation of diagnostic agents. London, 16 November 2000, CPMP/EWP/1119/98. Available at: www.eudra.org/emea.html. Accessed February 12, 2007
36. Poon E, Yucel EK, Pagan-Marin H, Kayne H. Iliac artery stenosis measurements: comparison of two-dimensional time-of-flight and three-dimensional dynamic gadolinium-enhanced MR angiography. AJR 1997; 169:1139-1144
37. Ho KY, de Haan MW, Kessels AG, Kitslaar PJ, van Engelshoven JM. Peripheral vascular tree stenoses: detection with subtracted and nonsubtracted MR angiography. Radiology 1998; 206:673-681
38. Thornton FJ, Du J, Suleiman SA, et al. High-resolution, time-resolved MRA provides superior definition of lower-extremity arterial segments compared to 2D time-of-flight imaging. J Magn Reson Imaging 2006; 24:362-370
39. Koelemay MJW, Lijmer JG, Stoker J, Legemate DA, Bossuyt PMM. Magnetic resonance angiography for the evaluation of lower extremity arterial disease: a meta-analysis. JAMA 2001; 285:1338-1345
40. Hamm B, Thoeni RF, Gould RG, et al. Focal liver lesions: characterization with nonenhanced and dynamic contrast material-enhanced MR imaging. Radiology 1994; 190:417-423
41. Schaefer PJ, Boudghene FP, Brambs HJ, et al. Abdominal and iliac arterial stenoses: comparative double-blinded randomized study of diagnostic accuracy of 3D MR angiography with gadodiamide or gadopentetate dimeglumine. Radiology 2006; 238:827-840
42. Rapp JH, Wolff SD, Quinn SF, et al. Aortoiliac occlusive disease in patients with known or suspected peripheral vascular disease: safety and efficacy of gadofosveset-enhanced MR angiography - multicenter comparative phase III study. Radiology 2005; 236:71-78
43. Goyen M, Edelman M, Perreault P, et al. MR angiography of aortoiliac occlusive disease: a phase III study of the safety and effectiveness of the blood-pool contrast agent MS-325. Radiology 2005; 236:825-833
44. Janka R, Fellner C, Wenkel E, Lang W, Bautz W, Fellner FA. Contrast-enhanced MR angiography of peripheral arteries including pedal vessels at 1.0 T: feasibility study with dedicated peripheral angiography coil. Radiology 2005; 235:319-326
45. Swan JS, Carroll TJ, Kennell TW, et al. Time-resolved three-dimensional contrast-enhanced MR angiography of the peripheral vessels. Radiology 2002; 225:43-52
46. Landi s JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33:159-174
47. Dujardin B, Van den Ende J, Van Gompel A, et al. Likelihood ratios: a real improvement for clinical decision making? Eur J Epidemiol 1994; 81:1546-1564
48. Jaeschke R, Guyatt JH, Sacket DL. Users' guides to the medical literature. III. How to use an article about a diagnostic test B: what are the results and will they help me in caring for my patients? The Evidence-Based Medicine Working Group. JAMA 1994; 271:703-707
49. Cortell ED, Kaufman JA, Geller SC, Cambria RP, Rivitz SM, Waltman AC. MR angiography of tibial runoff vessels: imaging with the head coil compared with conventional arteriography. AJR 1996; 167:147-151
50. Yucel KE, Kaufman JA, Geller SC, Waltman AC. Atherosclerotic occlusive disease of the lower extremity: prospective evaluation with two-dimensional time-of-flight MR angiography. Radiology 1993; 187:637-641
51. Snidow JJ, Harris VJ, Trerotola SO, et al. Interpretations and treatment decisions based on MR angiography versus conventional arteriography in symptomatic lower extremity ischemia. J Vasc Interv Radiol 1995; 6:595-603
52. Sueyoshi E, Sakamoto I, Matsuoka Y, et al. Aortoiliac and lower extremity arteries: comparison of three-dimensional dynamic contrast-enhanced subtraction MR angiography and conventional angiography. Radiology 1999; 210:683-688
53. Meaney JF, Ridgway JP, Chakraverty S, et al. Stepping-table gadolinium-enhanced digital subtraction MR angiography of the aorta and lower extremities arteries: preliminary experience. Radiology 1999; 211:59-67
54. Wang Y, Chen CZ, Chabra SG, et al. Bolus-arterialvenous transit in the lower extremity and venous contamination in bolus chase three-dimensional magnetic resonance angiography. Invest Radiol 2003; 37:458-463
55. Krause U, Kroencke T, Spielhaupter E, et al. Contrast-enhanced magnetic resonance angiography of the lower extremities: standard-dose vs. high-dose gadodiamide injection. J Magn Reson Imaging 2005; 21:449-454
56. Kroencke TJ, Wasser MN, Pattynama PMT, et al. Gadobenate dimeglumine-enhanced magnetic resonance angiography of the abdominal aorta and renal arteries. AJR 2002; 179:1573-1582
57. Wikström J, Wasser MN, Pattynama PMT, et al. Gadobenate dimeglumine-enhanced magnetic resonance angiography of the pelvic arteries. Invest Radiol 2003; 38:504-515
58. Laurent S, Elst LV, Muller RN. Comparative study of the physicochemical properties of six clinical low molecular weight gadolinium contrast agents. Contmst Media Mol Imaging 2006; 1:128-137
59. Broome DR, Girguis MS, Baron PW, Cottrell AC, Kjellin I, Kirk GA. Gadodiamide-associated nephrogenic systemic fibrosis: why radiologists should be concerned. AJR 2007; 188:586-592
60. Sadowski EA, Bennett LK, Chan MR, et al. Nephrogenic systemic fibrosis: risk factors and incidence estimation. Radiology 2007; 243:148-157
61. Kirchin MA, Runge VM. Contrast agents for magnetic resonance imaging: safety update. Top Magn Reson Imaging 2003; 14:426-435
62. Spinazzi A, Lorusso V, Pirovano G, Kirchin M. Safety, tolerance, biodistribution and MR imaging enhancement of the liver with gadobenate dimeglumine. Acad Radiol 1999; 6:282-291
63. Wilson GJ, Hoogeveen RM, Willinek WA, Muthupillai R, Maki JH. Parallel imaging in MR angiography. Top Magn Reson Imaging 2004; 15:169-185