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References MRI Safety Program: Gadolinium Based Contrast Media Safety Wm. Faulkner, B.S.,R.T.(R)(MR)(CT), FSMRT www.wfaulknerassociates.com Nihon Igaku Hoshasen Gakkai Zasshi. 1993 Aug 25;53(8):973-5. [Anaphylactoid reaction after

SLIDE 1

References MRI Safety Program: Gadolinium Based Contrast Media Safety

Wm. Faulkner, B.S.,R.T.(R)(MR)(CT), FSMRT

www.wfaulknerassociates.com

Nihon Igaku Hoshasen Gakkai Zasshi. 1993 Aug 25;53(8):973-5.

[Anaphylactoid reaction after intravenous administration of Gd-DTPA].  [Article in Japanese]

Acad Radiol. 1999 Nov;6(11):656-64.

Occurrence of adverse reactions to gadolinium-based contrast material and management of patients at increased risk: a survey of the American Society of Neuroradiology Fellowship Directors

J Magn Reson Imaging. 2001 Sep;14(3):281-94.

Safety assessment of gadobenate dimeglumine (MultiHance): extended clinical experience from phase I studies to post-marketing surveillance.  Kirchin MA, Pirovano G, Venetianer C, Spinazzi A.

Invest Radiol. 2006 Jun;41(6):500-9.

Safety of gadobenate dimeglumine (MultiHance): Summary of findings from clinical studies and postmarketing surveillance.  Shellock FG, Parker JR, Venetianer C, Pirovano G, Spinazzi A.

Invest Radiol. 2011 Nov;46(11):663-71. doi: 10.1097/RLI.0b013e3182218dc3.

Safety of gadobutrol, a new generation of contrast agents: experience from clinical trials and postmarketing surveillance.  Voth M, Rosenberg M, Breuer J.

Radiology. 2011 Apr;259(1):109-16. doi: 10.1148/radiol.10100906. Epub 2011 Jan 19.

Assessment of adverse reaction rates during gadoteridol-enhanced MR imaging in 28,078 patients.  Morgan DE, Spann JS, Lockhart ME, Winningham B, Bolus DN.

AJR Am J Roentgenol. 2007 Dec;189(6):1533-8.

Frequency and severity of acute allergic-like reactions to gadolinium-containing i.v. contrast media in children and adults.  Dillman JR, Ellis JH, Cohan RH, Strouse PJ, Jan SC.

Assessment of adverse reaction rates to a newly approved MRI contrast agent: review of

23,553 administrations of gadobenate dimeglumine.  Bleicher AG, Kanal E.  AJR Am J Roentgenol. 2008 Dec;191(6):W307-11. doi: 10.2214/AJR.07.3951

AJR Am J Roentgenol. 2015 Apr;204(4):703-6. doi: 10.2214/AJR.14.13430.

Assessment of rates of acute adverse reactions to gadobenate dimeglumine: review of more than 130,000 administrations in 7.5 years.  Fakhran S, Alhilali L, Kale H, Kanal E

Acta Radiol. 2012 Nov 1;53(9):953-4. doi: 10.1258/ar.2012.12a006.

The Lalli and Weber effects and the incidence of acute non-renal adverse reactions to contrast media.  Thomsen HS, Webb J.   

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Radiology. 2013 Mar;266(3):773-82. doi: 10.1148/radiol.12120253. Epub 2012 Dec 13.

Effect of abrupt substitution of gadobenate dimeglumine for gadopentetate dimeglumine on rate of allergic-like reactions.  Davenport MS, Dillman JR, Cohan RH, Hussain HK, Khalatbari S, McHugh JB, Ellis JH.

Am J Health Syst Pharm. 1995 Nov 15;52(22):2556-9.

Dosage of gadoteridol and adverse reactions relative to gadopentetate.  Hieronim DE, Kanal E, Swanson DP.

Indian J Dermatol. 2012 May;57(3):245. doi: 10.4103/0019-5154.96223.

Gadolinium-bound Contrast Agents: No Evidence-based Data to Support a Relationship Between Structure and Hypersensitivity Reactions.  Idee JM, Gaillard S, Corot C.

Invest Radiol. 2011 Nov;46(11):663-71. doi: 10.1097/RLI.0b013e3182218dc3.

Safety of gadobutrol, a new generation of contrast agents: experience from clinical trials and postmarketing surveillance.  Voth M, Rosenberg M, Breuer J.

Invest Radiol. 2001 Feb;36(2):65-71.
A clinical comparison of the safety and efficacy of MultiHance (gadobenate dimeglumine) and

Omniscan (Gadodiamide) in magnetic resonance imaging in patients with central nervous system pathology.  Runge VM, Armstrong MR, Barr RG, Berger BL, Czervionke LF, Gonzalez CF, Halford HH, Kanal E, Kuhn MJ, Levin JM, Low RN, Tanenbaum LN, Wang AM, Wong W, Yuh WT, Zoarski GH.

Fundam Clin Pharmacol. 2006 Dec;20(6):563-76.

Clinical and biological consequences of transmetallation induced by contrast agents for magnetic resonance imaging: a review.  Idée JM1, Port M, Raynal I, Schaefer M, Le Greneur S, Corot C.

Invest Radiol. 1996 Oct;31(10):619-24.

Comparative transmetallation kinetics and thermodynamic stability of gadolinium-DTPA bis- glucosamide and other magnetic resonance imaging contrast media.  Puttagunta NR1, Gibby WA, Puttagunta VL.

Top Magn Reson Imaging. 2003 Oct;14(5):426-35.

Contrast agents for magnetic resonance imaging: safety update.  Kirchin MA, Runge VM.

AJR Am J Roentgenol. 2007 Feb;188(2):586-92.

Gadodiamide-associated nephrogenic systemic fibrosis: why radiologists should be concerned.  Broome DR, Girguis MS, Baron PW, Cottrell AC, Kjellin I, Kirk GA

Radiology. 2003 Jun;227(3):639-46.

Gadodiamide administration causes spurious hypocalcemia.  Prince MR, Erel HE, Lent RW, Blumenfeld J, Kent KC, Bush HL, Wang Y.   

Page of 2 4

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Invest Radiol. 2006 Mar;41(3):272-8.

Comparison of Gd(DTPA-BMA) (Omniscan) versus Gd(HP-DO3A) (ProHance) relative to gadolinium retention in human bone tissue by inductively coupled plasma mass spectroscopy.  White GW1, Gibby WA, Tweedle MF.

Radiology. 2007 Apr;243(1):148-57. Epub 2007 Jan 31.

Nephrogenic systemic fibrosis: risk factors and incidence estimation.  Sadowski EA1, Bennett LK, Chan MR, Wentland AL, Garrett AL, Garrett RW, Djamali A.

Radiology. 2008 Sep;248(3):799-806. doi: 10.1148/radiol.2483072093. Epub 2008 Jul 15.

Risk of nephrogenic systemic fibrosis: evaluation of gadolinium chelate contrast agents at four American universities.  Wertman R, Altun E, Martin DR, Mitchell DG, Leyendecker JR, O'Malley RB, Parsons DJ, Fuller ER 3rd, Semelka RC.

Acta Radiol. 2010 Feb;51(1):78-84. doi: 10.3109/02841850903350178.

Low-dose contrast-enhanced magnetic resonance imaging of brain metastases at 3.0 T using high-relaxivity contrast agents.  Huang B, Liang CH, Liu HJ, Wang GY, Zhang SX.

Invest Radiol. 1996 Dec;31(12):739-42.

Human in vivo comparative study of zinc and copper transmetallation after administration of magnetic resonance imaging contrast agents.  Puttagunta NR, Gibby WA, Smith GT.

Radiat Med. 2005 Aug;23(5):322-6.

Human comparative study of zinc and copper excretion via urine after administration of magnetic resonance imaging contrast agents.  Kimura J, Ishiguchi T, Matsuda J, Ohno R, Nakamura A, Kamei S, Ohno K, Kawamura T, Murata K.

Radiology. 2009 May;251(2):503-10. doi: 10.1148/radiol.2511081269.

Multiple sclerosis: hyperintense dentate nucleus on unenhanced T1-weighted MR images is associated with the secondary progressive subtype.  Roccatagliata L, Vuolo L, Bonzano L, Pichiecchio A, Mancardi GL.

Radiology. 2011 Jan;258(1):222-8. doi: 10.1148/radiol.10100508. Epub 2010 Nov 2.

Hyperintense dentate nucleus on unenhanced T1-weighted MR images is associated with a history of brain irradiation.  Kasahara S, Miki Y, Kanagaki M, Yamamoto A, Mori N, Sawada T, Taoka T, Okada T,

Radiology. 2014 Mar;270(3):834-41. doi: 10.1148/radiol.13131669. Epub 2013 Dec 7.

High signal intensity in the dentate nucleus and globus pallidus on unenhanced T1-weighted MR images: relationship with increasing cumulative dose of a gadolinium-based contrast material.  Kanda T, Ishii K, Kawaguchi H, Kitajima K, Takenaka D.

Invest Radiol. 2014 Oct;49(10):685-90. doi: 10.1097/RLI.0000000000000072.

Progressive increase of T1 signal intensity of the dentate nucleus on unenhanced magnetic resonance images is associated with cumulative doses of intravenously administered gadodiamide in patients with normal renal function, suggesting dechelation.  Errante Y, Cirimele V, Mallio CA, Di Lazzaro V, Zobel BB, Quattrocchi CC. 

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Radiology. 2015 Jun;275(3):772-82. doi: 10.1148/radiol.15150025. Epub 2015 Mar 5.

Intracranial Gadolinium Deposition after Contrast-enhanced MR Imaging.  McDonald RJ, McDonald JS, Kallmes DF, Jentoft ME, Murray DL, Thielen KR, Williamson EE, Eckel LJ.

Radiology. 2015 Jun;275(3):803-9. doi: 10.1148/radiol.14140364. Epub 2015 Jan 27.

High Signal Intensity in Dentate Nucleus on Unenhanced T1-weighted MR Images: Association with Linear versus Macrocyclic Gadolinium Chelate Administration.  Kanda T, Osawa M, Oba H, Toyoda K, Kotoku J, Haruyama T, Takeshita K, Furui S.

Radiology. 2015 Jun;275(3):783-91. doi: 10.1148/radiol.2015150337. Epub 2015 Apr 6.

Gadolinium retention in the dentate nucleus and globus pallidus is dependent on the class of contrast agent.  Radbruch A, Weberling LD, Kieslich PJ, Eidel O, Burth S, Kickingereder P, Heiland S, Wick W, Schlemmer HP, Bendszus M.

Radiology. 2015 Jun;275(3):630-4. doi: 10.1148/radiol.2015150805. Epub 2015 May 5.

Residual or retained gadolinium: practical implications for radiologists and our patients.  Kanal E, Tweedle MF.

Radiology Podcast June 2015

http://youtu.be/gmgv6EvGw0o

Radiology. 2015 Apr 15:142423. [Epub ahead of print] Gadobenate Dimeglumine

Administration and Nephrogenic Systemic Fibrosis: Is There a Real Risk in Patients with Impaired Renal Function? Nandwana SB, Moreno CC, Osipow MT, Sekhar A, Cox KL

References MRI Safety Program: Gadolinium Based Contrast Media Safety

www.wfaulknerassociates.com

[Anaphylactoid reaction after intravenous administration of Gd-DTPA]. [Article in Japanese]

Occurrence of adverse reactions to gadolinium-based contrast material and management of patients at increased risk: a survey of the American Society of Neuroradiology Fellowship Directors

Safety assessment of gadobenate dimeglumine (MultiHance): extended clinical experience from phase I studies to post-marketing surveillance. Kirchin MA, Pirovano G, Venetianer C, Spinazzi A.

Safety of gadobenate dimeglumine (MultiHance): Summary of findings from clinical studies and postmarketing surveillance. Shellock FG, Parker JR, Venetianer C, Pirovano G, Spinazzi A.

Safety of gadobutrol, a new generation of contrast agents: experience from clinical trials and postmarketing surveillance. Voth M, Rosenberg M, Breuer J.

Assessment of adverse reaction rates during gadoteridol-enhanced MR imaging in 28,078 patients. Morgan DE, Spann JS, Lockhart ME, Winningham B, Bolus DN.

Frequency and severity of acute allergic-like reactions to gadolinium-containing i.v. contrast media in children and adults. Dillman JR, Ellis JH, Cohan RH, Strouse PJ, Jan SC.

23,553 administrations of gadobenate dimeglumine. Bleicher AG, Kanal E. AJR Am J Roentgenol. 2008 Dec;191(6):W307-11. doi: 10.2214/AJR.07.3951

Assessment of rates of acute adverse reactions to gadobenate dimeglumine: review of more than 130,000 administrations in 7.5 years. Fakhran S, Alhilali L, Kale H, Kanal E

The Lalli and Weber effects and the incidence of acute non-renal adverse reactions to contrast media. Thomsen HS, Webb J.

Page of 1 4

Effect of abrupt substitution of gadobenate dimeglumine for gadopentetate dimeglumine on rate of allergic-like reactions. Davenport MS, Dillman JR, Cohan RH, Hussain HK, Khalatbari S, McHugh JB, Ellis JH.

Dosage of gadoteridol and adverse reactions relative to gadopentetate. Hieronim DE, Kanal E, Swanson DP.

Gadolinium-bound Contrast Agents: No Evidence-based Data to Support a Relationship Between Structure and Hypersensitivity Reactions. Idee JM, Gaillard S, Corot C.

Safety of gadobutrol, a new generation of contrast agents: experience from clinical trials and postmarketing surveillance. Voth M, Rosenberg M, Breuer J.

Omniscan (Gadodiamide) in magnetic resonance imaging in patients with central nervous system pathology. Runge VM, Armstrong MR, Barr RG, Berger BL, Czervionke LF, Gonzalez CF, Halford HH, Kanal E, Kuhn MJ, Levin JM, Low RN, Tanenbaum LN, Wang AM, Wong W, Yuh WT, Zoarski GH.

Clinical and biological consequences of transmetallation induced by contrast agents for magnetic resonance imaging: a review. Idée JM1, Port M, Raynal I, Schaefer M, Le Greneur S, Corot C.

Comparative transmetallation kinetics and thermodynamic stability of gadolinium-DTPA bis- glucosamide and other magnetic resonance imaging contrast media. Puttagunta NR1, Gibby WA, Puttagunta VL.

Contrast agents for magnetic resonance imaging: safety update. Kirchin MA, Runge VM.

Gadodiamide-associated nephrogenic systemic fibrosis: why radiologists should be concerned. Broome DR, Girguis MS, Baron PW, Cottrell AC, Kjellin I, Kirk GA

Gadodiamide administration causes spurious hypocalcemia. Prince MR, Erel HE, Lent RW, Blumenfeld J, Kent KC, Bush HL, Wang Y.

Page of 2 4

Comparison of Gd(DTPA-BMA) (Omniscan) versus Gd(HP-DO3A) (ProHance) relative to gadolinium retention in human bone tissue by inductively coupled plasma mass spectroscopy. White GW1, Gibby WA, Tweedle MF.

Nephrogenic systemic fibrosis: risk factors and incidence estimation. Sadowski EA1, Bennett LK, Chan MR, Wentland AL, Garrett AL, Garrett RW, Djamali A.

Risk of nephrogenic systemic fibrosis: evaluation of gadolinium chelate contrast agents at four American universities. Wertman R, Altun E, Martin DR, Mitchell DG, Leyendecker JR, O'Malley RB, Parsons DJ, Fuller ER 3rd, Semelka RC.

Low-dose contrast-enhanced magnetic resonance imaging of brain metastases at 3.0 T using high-relaxivity contrast agents. Huang B, Liang CH, Liu HJ, Wang GY, Zhang SX.

Human in vivo comparative study of zinc and copper transmetallation after administration of magnetic resonance imaging contrast agents. Puttagunta NR, Gibby WA, Smith GT.

Human comparative study of zinc and copper excretion via urine after administration of magnetic resonance imaging contrast agents. Kimura J, Ishiguchi T, Matsuda J, Ohno R, Nakamura A, Kamei S, Ohno K, Kawamura T, Murata K.

Multiple sclerosis: hyperintense dentate nucleus on unenhanced T1-weighted MR images is associated with the secondary progressive subtype. Roccatagliata L, Vuolo L, Bonzano L, Pichiecchio A, Mancardi GL.

Hyperintense dentate nucleus on unenhanced T1-weighted MR images is associated with a history of brain irradiation. Kasahara S, Miki Y, Kanagaki M, Yamamoto A, Mori N, Sawada T, Taoka T, Okada T,

High signal intensity in the dentate nucleus and globus pallidus on unenhanced T1-weighted MR images: relationship with increasing cumulative dose of a gadolinium-based contrast material. Kanda T, Ishii K, Kawaguchi H, Kitajima K, Takenaka D.

Page of 3 4

Intracranial Gadolinium Deposition after Contrast-enhanced MR Imaging. McDonald RJ, McDonald JS, Kallmes DF, Jentoft ME, Murray DL, Thielen KR, Williamson EE, Eckel LJ.

High Signal Intensity in Dentate Nucleus on Unenhanced T1-weighted MR Images: Association with Linear versus Macrocyclic Gadolinium Chelate Administration. Kanda T, Osawa M, Oba H, Toyoda K, Kotoku J, Haruyama T, Takeshita K, Furui S.

Gadolinium retention in the dentate nucleus and globus pallidus is dependent on the class of contrast agent. Radbruch A, Weberling LD, Kieslich PJ, Eidel O, Burth S, Kickingereder P, Heiland S, Wick W, Schlemmer HP, Bendszus M.

Residual or retained gadolinium: practical implications for radiologists and our patients. Kanal E, Tweedle MF.

http://youtu.be/gmgv6EvGw0o

Administration and Nephrogenic Systemic Fibrosis: Is There a Real Risk in Patients with Impaired Renal Function? Nandwana SB, Moreno CC, Osipow MT, Sekhar A, Cox KL

Page of 4 4

[Anaphylactoid reaction after intravenous administration of Gd-DTPA].  [Article in Japanese]

Safety assessment of gadobenate dimeglumine (MultiHance): extended clinical experience from phase I studies to post-marketing surveillance.  Kirchin MA, Pirovano G, Venetianer C, Spinazzi A.

Safety of gadobenate dimeglumine (MultiHance): Summary of findings from clinical studies and postmarketing surveillance.  Shellock FG, Parker JR, Venetianer C, Pirovano G, Spinazzi A.

Safety of gadobutrol, a new generation of contrast agents: experience from clinical trials and postmarketing surveillance.  Voth M, Rosenberg M, Breuer J.

Assessment of adverse reaction rates during gadoteridol-enhanced MR imaging in 28,078 patients.  Morgan DE, Spann JS, Lockhart ME, Winningham B, Bolus DN.

Frequency and severity of acute allergic-like reactions to gadolinium-containing i.v. contrast media in children and adults.  Dillman JR, Ellis JH, Cohan RH, Strouse PJ, Jan SC.

23,553 administrations of gadobenate dimeglumine.  Bleicher AG, Kanal E.  AJR Am J Roentgenol. 2008 Dec;191(6):W307-11. doi: 10.2214/AJR.07.3951

Assessment of rates of acute adverse reactions to gadobenate dimeglumine: review of more than 130,000 administrations in 7.5 years.  Fakhran S, Alhilali L, Kale H, Kanal E

The Lalli and Weber effects and the incidence of acute non-renal adverse reactions to contrast media.  Thomsen HS, Webb J.   

Effect of abrupt substitution of gadobenate dimeglumine for gadopentetate dimeglumine on rate of allergic-like reactions.  Davenport MS, Dillman JR, Cohan RH, Hussain HK, Khalatbari S, McHugh JB, Ellis JH.

Dosage of gadoteridol and adverse reactions relative to gadopentetate.  Hieronim DE, Kanal E, Swanson DP.

Gadolinium-bound Contrast Agents: No Evidence-based Data to Support a Relationship Between Structure and Hypersensitivity Reactions.  Idee JM, Gaillard S, Corot C.

Safety of gadobutrol, a new generation of contrast agents: experience from clinical trials and postmarketing surveillance.  Voth M, Rosenberg M, Breuer J.

Omniscan (Gadodiamide) in magnetic resonance imaging in patients with central nervous system pathology.  Runge VM, Armstrong MR, Barr RG, Berger BL, Czervionke LF, Gonzalez CF, Halford HH, Kanal E, Kuhn MJ, Levin JM, Low RN, Tanenbaum LN, Wang AM, Wong W, Yuh WT, Zoarski GH.

Clinical and biological consequences of transmetallation induced by contrast agents for magnetic resonance imaging: a review.  Idée JM1, Port M, Raynal I, Schaefer M, Le Greneur S, Corot C.

Comparative transmetallation kinetics and thermodynamic stability of gadolinium-DTPA bis- glucosamide and other magnetic resonance imaging contrast media.  Puttagunta NR1, Gibby WA, Puttagunta VL.

Contrast agents for magnetic resonance imaging: safety update.  Kirchin MA, Runge VM.

Gadodiamide-associated nephrogenic systemic fibrosis: why radiologists should be concerned.  Broome DR, Girguis MS, Baron PW, Cottrell AC, Kjellin I, Kirk GA

Gadodiamide administration causes spurious hypocalcemia.  Prince MR, Erel HE, Lent RW, Blumenfeld J, Kent KC, Bush HL, Wang Y.   

Comparison of Gd(DTPA-BMA) (Omniscan) versus Gd(HP-DO3A) (ProHance) relative to gadolinium retention in human bone tissue by inductively coupled plasma mass spectroscopy.  White GW1, Gibby WA, Tweedle MF.

Nephrogenic systemic fibrosis: risk factors and incidence estimation.  Sadowski EA1, Bennett LK, Chan MR, Wentland AL, Garrett AL, Garrett RW, Djamali A.

Risk of nephrogenic systemic fibrosis: evaluation of gadolinium chelate contrast agents at four American universities.  Wertman R, Altun E, Martin DR, Mitchell DG, Leyendecker JR, O'Malley RB, Parsons DJ, Fuller ER 3rd, Semelka RC.

Low-dose contrast-enhanced magnetic resonance imaging of brain metastases at 3.0 T using high-relaxivity contrast agents.  Huang B, Liang CH, Liu HJ, Wang GY, Zhang SX.

Human in vivo comparative study of zinc and copper transmetallation after administration of magnetic resonance imaging contrast agents.  Puttagunta NR, Gibby WA, Smith GT.

Human comparative study of zinc and copper excretion via urine after administration of magnetic resonance imaging contrast agents.  Kimura J, Ishiguchi T, Matsuda J, Ohno R, Nakamura A, Kamei S, Ohno K, Kawamura T, Murata K.

Multiple sclerosis: hyperintense dentate nucleus on unenhanced T1-weighted MR images is associated with the secondary progressive subtype.  Roccatagliata L, Vuolo L, Bonzano L, Pichiecchio A, Mancardi GL.

Hyperintense dentate nucleus on unenhanced T1-weighted MR images is associated with a history of brain irradiation.  Kasahara S, Miki Y, Kanagaki M, Yamamoto A, Mori N, Sawada T, Taoka T, Okada T,

High signal intensity in the dentate nucleus and globus pallidus on unenhanced T1-weighted MR images: relationship with increasing cumulative dose of a gadolinium-based contrast material.  Kanda T, Ishii K, Kawaguchi H, Kitajima K, Takenaka D.

Intracranial Gadolinium Deposition after Contrast-enhanced MR Imaging.  McDonald RJ, McDonald JS, Kallmes DF, Jentoft ME, Murray DL, Thielen KR, Williamson EE, Eckel LJ.

High Signal Intensity in Dentate Nucleus on Unenhanced T1-weighted MR Images: Association with Linear versus Macrocyclic Gadolinium Chelate Administration.  Kanda T, Osawa M, Oba H, Toyoda K, Kotoku J, Haruyama T, Takeshita K, Furui S.

Gadolinium retention in the dentate nucleus and globus pallidus is dependent on the class of contrast agent.  Radbruch A, Weberling LD, Kieslich PJ, Eidel O, Burth S, Kickingereder P, Heiland S, Wick W, Schlemmer HP, Bendszus M.

Residual or retained gadolinium: practical implications for radiologists and our patients.  Kanal E, Tweedle MF.