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Pediatric Radiology

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01.02.2013 | Original Article

Safety and adverse effects during 24 hours after contrast-enhanced MRI with gadobenate dimeglumine (MultiHance®) in children

verfasst von: Guenther Schneider, Hellmut Schürholz, Miles A. Kirchin, Arno Bücker, Peter Fries

Erschienen in: Pediatric Radiology | Ausgabe 2/2013

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Abstract

Background

Gadolinium-based MR contrast agents have long been considered safe for routine diagnostic imaging. However, the advent of nephrogenic systemic fibrosis (NSF) among certain patients with severe renal insufficiency has brought the issue of safety into question. Nowhere is safety of greater concern than among children who frequently require multiple contrast-enhanced MRI examinations over an extended period of time.

Objective

To retrospectively evaluate the safety of gadobenate dimeglumine for contrast-enhanced (CE) MRI across a range of indications.

Materials and methods

Two hundred pediatric inpatients (age: 4 days to 15 years) underwent CE MRI as part of clinical routine. The children received a gadobenate dimeglumine dose of either 0.05 mmol/kg body weight (liver, abdominal imaging, musculoskeletal imaging, brain and other rare indications) or 0.1 mmol/kg bodyweight (cardiovascular imaging, MR-urography). Young (< 8 years) children with congenital heart disease were intubated and underwent MRA evaluation with controlled ventilation. Monitoring for adverse events was performed for at least 24 h after each gadobenate dimeglumine injection. Depending on clinical necessity, laboratory measurements and, in some cases, vital sign and ECG determinations were made before and after contrast injection. Safety was evaluated by age group, indication and dose administered.

Results

No clinically adverse events were reported among children who had one MRI scan only or among children who had several examinations. There were no changes in creatinine or bilirubin levels even in very young children.

Conclusions

No adverse events were recorded during the first 24 h following administration of gadobenate dimeglumine in 200 children.

Carr JJ (1994) Magnetic resonance contrast agents for neuroimaging. Safety issues. Neuroimaging Clin N Am 4:43–54PubMed

Nelson KL, Gifford LM, Lauber-Huber C et al (1995) Clinical safety of gadopentetate dimeglumine. Radiology 196:439–443

Ekholm S, Jonsson E, Sandvik L et al (1996) Tolerance and efficacy on Omniscan (Gd-DTPA-BMA injection) in MR imaging of the central nervous system. Acta Radiologica 37:223–228PubMed

Tresley RM, Stone LA, Fields N et al (1997) Clinical safety of serial monthly administrations of gadopentetate dimeglumine in patients with multiple sclerosis: implications for natural history and early-phase treatment trials. Neurology 48:832–835

Runge VM, Parker JR (1997) Worldwide clinical safety assessment of gadoteridol injection: an update. Eur Radiol 7(Suppl 5):243–245PubMedCrossRef

Shellock FG, Kanal E (1999) Safety of magnetic resonance imaging contrast agents. J Magn Reson Imaging 10:477–484PubMedCrossRef

Niendorf HP, Kallend D (1999) Gadolinium chelates: adverse reactions. In: Dawson P, Cosgrove DO, Grainger RG (eds) Textbook of contrast media. ISIS Medical Media, Oxford, UK, pp 323–332

Swan SK, Baker JF, Free R et al (1999) Pharmacokinetics, safety, and tolerability of gadoversetamide injection (OptiMARK) in subjects with central nervous system or liver pathology and varying degrees of renal function. J Magn Reson Imaging 9:317–321PubMedCrossRef

Rubin DL, Desser TS, Semelka R et al (1999) A multicenter, randomized, double-blind study to evaluate the safety, tolerability, and efficacy of OptiMARK (gadoversetamide injection) compared with Magnevist (gadopentetate dimeglumine) in patients with liver pathology: results of a Phase III clinical trial. J Magn Reson Imaging 9:240–250PubMedCrossRef

10.

Runge VM (2000) Safety of approved MR contrast media for intravenous injection. J Magn Reson Imaging 12:205–213PubMedCrossRef

11.

Runge VM (2001) Safety of magnetic resonance contrast media. Top Magn Reson Imaging 12:309–314PubMedCrossRef

12.

De Ridder F, De Maeseneer M, Stadnik T et al (2001) Severe adverse reactions with contrast agents for magnetic resonance: clinical experience in 30,000 MR examinations. JBR-BTR 84:150–152

13.

Kirchin MA, Runge VM (2003) Contrast agents for magnetic resonance imaging: safety update. Top Magn Reson Imaging 14:426–435PubMedCrossRef

14.

Baker JF, Kratz LC, Stevens GR et al (2004) Pharmacokinetics and safety of the MRI contrast agent gadoversetamide injection (OptiMARK) in healthy pediatric subjects. Invest Radiol 39:334–339

15.

Bellin MF, Webb JA, Van Der Molen AJ et al (2005) Safety of MR liver specific contrast media. Eur Radiol 15:1607–1614PubMedCrossRef

16.

Webb JA, Thomsen HS, Morcos SK et al (2005) The use of iodinated and gadolinium contrast media during pregnancy and lactation. Eur Radiol 15:1234–1240PubMedCrossRef

17.

Knopp MV, Balzer T, Esser M et al (2006) Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use. Invest Radiol 41:491–499, Erratum in: Invest Radiol 41:667

18.

Garcia-Bournissen F, Shrim A, Koren G (2006) Safety of gadolinium during pregnancy. Can Fam Physician 52:309–310PubMed

19.

Bourrinet P, Martel E, El Amrani AI et al (2007) Cardiovascular safety of gadoterate meglumine (Gd-DOTA). Invest Radiol 42:63–77PubMedCrossRef

20.

Li A, Wong CS, Wong MK et al (2006) Acute adverse reactions to magnetic resonance contrast media--gadolinium chelates. Br J Radiol 79(941):368–371, Erratum in: Br J Radiol 80:145

21.

Thomsen HS (2006) Nephrogenic systemic fibrosis: A serious late adverse reaction to gadodiamide. Eur Radiol 16:2619–2621PubMedCrossRef

22.

Marckmann P, Skov L, Rossen K et al (2006) Nephrogenic systemic fibrosis: suspected causative role of gadodiamide used for contrast-enhanced magnetic resonance imaging. J Am Soc Nephrol 17:2359–2362PubMedCrossRef

23.

Broome DR, Girguis MS, Baron PW et al (2007) Gadodiamide-associated nephrogenic systemic fibrosis: why radiologists should be concerned. AJR 188:586–592

24.

Sadowski EA, Bennett LK, Chan MR et al (2007) Nephrogenic systemic fibrosis: risk factors and incidence estimation. Radiology 243:148–157PubMedCrossRef

25.

Kanal E, Barkovich AJ, Bell C et al (2007) ACR Blue Ribbon Panel on MR Safety. ACR guidance document for safe MR practices: 2007. AJR 188:1447–1474

26.

Penfield JG, Reilly RF (2008) Nephrogenic systemic fibrosis risk: is there a difference between gadolinium-based contrast agents? Semin Dial 21:129–134PubMedCrossRef

27.

Kirchin MA, Pirovano G, Venetianer C et al (2001) Safety assessment of gadobenate dimeglumine (Multihance®): extended clinical experience from phase I studies to post-marketing surveillance. J Magn Reson Imaging 14:281–294

28.

Shellock FG, Parker JR, Venetianer C et al (2006) Safety of gadobenate dimeglumine: summary of findings from clinical studies and post-marketing surveillance. Invest Radiol 41:500–509

29.

Shellock FG, Parker JR, Pirovano G et al (2006) Safety characteristics of gadobenate dimeglumine: Clinical experience from intra- and interindividual comparison studies with gadopentetate dimeglumine. J Magn Reson Imaging 24:1378–1385

30.

Bleicher AG, Kanal E (2008) Assessment of adverse reaction rates to a newly approved MRI contrast agent: review of 23,553 administrations of gadobenate dimeglumine. AJR 191:W307–W311

31.

Herborn CU, Jäger-Booth I, Lodemann KP et al (2009) [Multicenter analysis of tolerance and clinical safety of the extracellular MR contrast agent gadobenate dimeglumine (MultiHance)]. Rofo 181:652–657

32.

Pintaske J, Martirosian P, Graf H et al (2006) 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 41:213–221, Erratum in: Invest Radiol 41:859

33.

Bleicher AG, Kanal E (2008) A serial dilution study of gadolinium-based MR imaging contrast agents. AJNR 29:668–673

34.

Giesel FL, von Tengg-Kobligk H, Wilkinson ID et al (2006) Influence of human serum albumin on longitudinal and transverse relaxation rates (R1 and R2) of magnetic resonance contrast agents. Invest Radiol 41:222–228PubMedCrossRef

35.

Spinazzi A, Lorusso V, Pirovano G et al (1999) Safety, tolerance, biodistribution and MR imaging enhancement of the liver with gadobenate dimeglumine. Acad Radiol 6:282–291

36.

Grazioli L, Morana G, Federle MP et al (2001) Focal nodular hyperplasia: morphological and functional information from MR imaging with gadobenate dimeglumine. Radiology 221:731–739PubMedCrossRef

37.

Schneider G, Maas R, Schultze Kool L et al (2003) Low-dose gadobenate dimeglumine versus standard dose gadopentetate dimeglumine for contrast-enhanced magnetic resonance imaging of the liver: an intra-individual crossover comparison. Invest Radiol 38:85–94

38.

Grazioli L, Morana G, Kirchin MA et al (2005) Accurate differentiation of focal nodular hyperplasia from hepatic adenoma at gadobenate dimeglumine – enhanced MR imaging: prospective study. Radiology 236:166–177

39.

Colosimo C, Demaerel P, Tortori-Donati P et al (2005) Comparison of gadobenate dimeglumine (Gd-BOPTA) with gadopentetate dimeglumine (Gd-DTPA) for enhanced MR imaging of brain and spine tumors in pediatric subjects. Pediatr Radiol 35:501–510PubMedCrossRef

40.

Savory DJ (1990) Reference ranges for serum creatinine in infants, children and adolescents. Ann Clin Biochem 27(Pt 2):99–101PubMed

41.

Knopp MV, Giesel FL, von Tengg-Kobligk H et al (2003) Contrast-enhanced MR angiography of the run-off vasculature: intraindividual comparison of gadobenate dimeglumine with gadopentetate dimeglumine. J Magn Reson Imaging 17:694–702PubMedCrossRef

42.

Gerretsen SC, le Maire TF, Miller S et al (2010) Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for MR angiography of peripheral arteries. Radiology 255:988–1000PubMedCrossRef

43.

Bültmann E, Erb G, Kirchin MA et al (2008) Intra-individual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for contrast-enhanced MR angiography of the supraaortic vessels at 3 Tesla. Invest Radiol 43:695–702

44.

Pediconi F, Fraioli F, Catalano C et al (2003) 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 106:87–93PubMed

45.

Prokop M, Schneider G, Vanzulli A et al (2005) Contrast-enhanced MR Angiography of the renal arteries: blinded multicenter crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine. Radiology 234:399–408

46.

Stein PD, Chenevert TL, Fowler SE et al (2010) Gadolinium-enhanced magnetic resonance angiography for pulmonary embolism: a multicenter prospective study (PIOPED III). Ann Intern Med 152:434–443PubMedCrossRef

47.

Woodard PK, Chenevert TL, Sostman HD et al (2012) Signal quality of single dose gadobenate dimeglumine pulmonary MRA examinations exceeds quality of MRA performed with double dose gadopentetate dimeglumine. Int J Cardiovasc Imaging 28:295–301PubMedCrossRef

48.

Achenbach M, Figiel JH, Burbelko M et al (2010) Prospective comparison of image quality and diagnostic accuracy of 0.5 molar gadobenate dimeglumine and 1.0 molar gadobutrol in contrast-enhanced run-off magnetic resonance angiography of the lower extremities. J Magn Reson Imaging 32:1166–1171

49.

Balci NC, Inan N, Anik Y et al (2006) Low-dose gadobenate dimeglumine versus standard-dose gadopentate dimeglumine for delayed contrast-enhanced cardiac magnetic resonance imaging. Acad Radiol 13:833–839

50.

Li Y, Li X, Li D et al (2012) Multicenter, intra-individual comparison of single dose gadobenate dimeglumine and double dose gadopentetate dimeglumine for MR Angiography of the supra-aortic arteries (the supra-aortic VALUE study). AJNR. doi:10.3174/ajnr.A3298

51.

Tomasian A, Salamon N, Lohan DG et al (2008) Supraaortic arteries: contrast material dose reduction at 3.0-T high-spatial-resolution MR angiography–feasibility study. Radiology 249:980–990

52.

Penfield JG (2008) Nephrogenic systemic fibrosis and the use of gadolinium-based contrast agents. Pediatr Nephrol 23:2121–2129PubMedCrossRef

53.

Mendichovszky IA, Marks SD, Simcock CM et al (2008) Gadolinium and nephrogenic systemic fibrosis: time to tighten practice. Pediatr Radiol 38:489–496

54.

Pirovano G, Munley J, Schultz C et al (2012) Nephrogenic systemic fibrosis: a review of published cases and results from three prospective observational studies. Presented at European Congress of Radiology, Vienna, Austria; March 1–5.

Titel: Safety and adverse effects during 24 hours after contrast-enhanced MRI with gadobenate dimeglumine (MultiHance®) in children
verfasst von: Guenther Schneider
Hellmut Schürholz
Miles A. Kirchin
Arno Bücker
Peter Fries
Publikationsdatum: 01.02.2013
Verlag: Springer Berlin Heidelberg
Erschienen in: Pediatric Radiology / Ausgabe 2/2013
Print ISSN: 0301-0449
Elektronische ISSN: 1432-1998
DOI: https://doi.org/10.1007/s00247-012-2498-8

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Safety and adverse effects during 24 hours after contrast-enhanced MRI with gadobenate dimeglumine (MultiHance®) in children

Abstract

Background

Objective

Materials and methods

Results

Conclusions

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Springer Medizin

Abstract

Background

Objective

Materials and methods

Results

Conclusions

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