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THE DIAGNOSTIC EFFICACY AND SAFETY OF MACROCYCLIC GADOLINIUM-BASED MAGNETIC RESONANCE CONTRAST AGENTS

https://doi.org/10.20862/0042-4676-2017-98-3-159-166

Abstract

The paper provides information on the safety and diagnostic efficacy of macrocyclic magnetic resonance contrast agents, such as gadobutrol, gadoteridol, and gadoteric acid. It is concluded that the standard gadobutrol dose of 0.1 mmol/kg body weight has a favorable safety profile and is well tolerated by children, including by newborn infants and adults. Owing to the increased relaxivity and double concentration of gadolinium, gadobutrol, as compared to gadoteridol and gadoteric acid, has a higher diagnostic efficacy and pharmacoeconomic advantages.

About the Authors

V. O. Panov
Russian Medical Academy of Continuing Professional Education, Ministry of Health of the Russia
Russian Federation
MD, PhD, Associate Professor of Chair of Radiation Diagnosis, Radiotherapy and Medical Physics


N. L. Shimanovskiy
Pirogov Russian National Research Medical University, Ministry of Health of the Russia
Russian Federation
MD, PhD, DSc, Professor, Corresponding Member of Russian Academy of Sciences, Chief of Chair of Molecular Pharmacology and Radiobiology named after P.V. Sergeev


References

1. Панов В.О., Шимановский Н.Л. Имеет ли клиническое значение стабильность гадолинийсодержащих магнитно-резонансных контрастных средств? Вестник рентгенологии и радиологии. 2016; 97 (4): 243–56. [Panov V.O., Shimanovskiy N.L. Has the stability of gadoliniumbased magnetic resonance contrast media the clinical significance? Vestnik Rentgenologii i Radiologii (Russian Journal of Radiology). 2016; 97 (4): 243–56 (in Russ.).]

2. European Committee Releases New Recommendations on Gadoliniumbased Contrast Agents. https://www. itnonline.com/content/europeancommittee-releases-new-recommendations-gadolinium-basedcontrast-agents (дата обращения 11.05.2017).

3. Kromrey M.L., Liedtke K.R., Ittermann T., Langner S., Kirsch M., Weitschies W., Kühn J.P. Intravenous injection of gadobutrol in an epidemiological study group did not lead to a difference in relative signal intensities of certain brain structures after 5 years. Eur. Radiol. 2017; 27 (2): 772–7.

4. Frenzel T., Lengsfeld P., Schirmer H., Hutter J., Weinmann H.J. Stability of gadolinium-based magnetic resonance imaging contrast agents in human serum at 37 degrees C. Invest. Radiol. 2008; 43 (12): 817–28.

5. Schmitt-Willich H. Stability of linear and macrocyclic gadolinium based contrast agents. Br. J. Radiol. 2007; 80 (955): 581–2.

6. Staks T., Schuhmann-Giampieri G., Frenzel T., Weinmann H.J., Lange L., Platzek J. Pharmacokinetics, dose proportionality, and tolerability of gadobutrol after single intravenous injection in healthy volunteers. Invest. Radiol. 1994; 29 (7): 709–15.

7. Tombach B., Heindel W. Value of 1.0-M gadolinium chelates: review of preclinical and clinical data on gadobutrol. Eur. Radiol. 2002; 12 (6): 1550–6.

8. Balzer J.O., Loewe C., Davis K., Goyen M., Leiner T., Meaney J.F. et al. Safety of contrast-enhanced MR angiography employing gadobutrol 1.0 M as contrast material. Eur. Radiol. 2003; 13 (9): 2067–74.

9. Huppertz A., Rohrer M. Gadobutrol, a highly concentrated MRimaging contrast agent: its physicochemical characteristics and the basis for its use in contrast-enhanced MR angiography and perfusion imaging. Eur. Radiol. 2004; 14 (Suppl. 5): M12–8.

10. Vogler H., Platzek J., SchuhmannGiampieri G., Frenzel T., Weinmann H.J., Raduchel B., Press W.R. Pre-clinical evaluation of gadobutrol: a new, neutral, extracellular contrast agent for magnetic resonance imaging. Eur. J. Radiol. 1995; 21 (1): 1–10.

11. Tombach B., Bremer C., Reimer P., Matzkies F., Schaefer R.M., Ebert W. et al. Using highly concentrated gadobutrol as an MR contrast agent in patients also requiring hemodialysis: safety and dialysability. Am. J. Roentgenol. 2002; 178 (1): 105–9.

12. Kunze C., Mentzel H.-J., Krishnamurthy R., Fleck R. Pharmacokinetics and safety of macrocyclic gadobutrol in children aged younger than 2 years including term newborns in comparison to older populations. Invest. Radiol. 2016; 51: 50–7.

13. Долгушин Б.И., Тюрин И.Е. Стандарты УЗИ, РКТ, МРТ и ПЭТ/КТ-исследований в онкологии. 5-е изд., доп. М.: РОНЦ; 2016. [Dolgushin B.I., Tyurin I.E. Standards of ultrasound, CT, MRI and PET/CT examinations in oncology. 5th ed. Moscow; 2016 (in Russ.).]

14. Montalban X., Tintoré M., Swanton J. et al. MRI criteria for MS in patients with clinically isolated syndromes. Neurology. 2010; 74: 427–34.

15. Polman C.H., Reingold S.C., Banwell B., Clanet M. Diagnostic criteria for multiple sclerosis: 2010 Revisions to the McDonald criteria. Ann. Neurol. 2011; 69: 292–302.

16. Rohrer M., Bauer H., Mintorovitch J., Requardt M., Weinmann H.J. Comparison of magnetic properties of MRI contrast media solutions at different magnetic field strengths. Invest. Radiol. 2005; 40 (11): 715–24.

17. Anzalone N., Scarabino T., Venturi C., Cristaudo C., Tartaro A., Scotti G. et al. Cerebral neoplastic enhancing lesions: multicenter, randomized, crossover intraindividual comparison between gadobutrol (1.0 M) and gadoterate meglumine (0.5 M) at 0.1 mmol Gd/kg body weight in a clinical setting. Eur. J. Radiol. 2013; 82 (1): 139–45.

18. Kramer H., Runge V.M., Naul L.G., Loynachan A.T., Reiser M.F., Wintersperger B.J. Brain MRI with single-dose (0.1 mmol/kg) Gadobutrol at 1.5 T and 3 T: comparison with 0.15 mmol/kg Gadoterate Meglumine. Am. J. Roentgenol. 2010; 194 (5): 1337–42.

19. Katakami N., Inaba Y., Sugata S. et al. Magnetic resonance evaluation of brain metastases from systemic malignances with two doses of Gadobutrol 1.0 M compared with Gadoteridol. Invest. Radiol. 2011; 46: 411–8.

20. Koenig M., Schulte-Altedorneburg G., Piontek M., Hentsch A., Spangenberg P., Schwenke C. et al. Intra-individual, randomised comparison of the MRI contrast agents gadobutrol versus gadoteridol in patients with primary and secondary brain tumours, evaluated in a blinded read. Eur. Radiol. 2013; 23 (12): 3287–95.

21. Gutierrez J.E., Rosenberg M., Seemann J., Breuer J., Haverstock D., Agris J. et al. Safety and efficacy of Gadobutrol for contrast-enhanced magnetic resonance imaging of the central nervous system: results from a multicenter, double-blind, randomized, comparator study. Magn. Reson. Insights. 2015; 7 (8): 1–10.

22. Wagner M., Schilling R., Doeblin P., Huppertz A., Luhur R., Schwenke C. et al. Macrocyclic contrast agents for magnetic resonance imaging of chronic myocardial infarction: intraindividual comparison of gadobutrol and gadoterate meglumine. Eur. Radiol. 2013; 23 (1): 108–14.

23. Voth M., Attenberger U., Luckscheiter A., Haneder S., Henzler T., Schoenberg S. et al. “Number needed to read” – how to facilitate clinical trials in MR-angiography. Eur. Radiol. 2011; 21 (5): 1034–42.

24. Haneder S., Attenberger U.I., Schoenberg S.O., Loewe C., Arnaiz J., Michaely H.J. Comparison of 0.5 M gadoterate and 1.0 M gadobutrol in peripheral MRA: a prospective, single-center, randomized, crossover, double-blind study. J. Magn. Reson. Imaging. 2012; 36 (5): 1213–21.

25. Fallenberg E.M., Renz D.M., Karle B., Schwenke C., Ingod-Heppner B., Reles A. et al. Intraindividual, randomized comparison of the macrocyclic contrast agents gadobutrol and gadoterate meglumine in breast magnetic resonance imaging. Eur. Radiol. 2015; 25 (3): 837–49.

26. Кармазановский Г.Г., Барышев П.М., Шимановский Н.Л. Фармакоэкономическая оценка применения одномолярного гадолинийсодержащего магнитно-резонансного контрастного средства по сравнению с полумолярными препаратами для диагностики заболеваний центральной нервной системы. Медицинская визуализация. 2012; 4: 113–7. [Karmazanovskiy G.G., Baryshev P.M., Shimanovskiy N.L. Pharmacoeconomic evaluation of the use of one molar gadolinium magnetic resonance contrast agent compared to the half molar agents for the diagnosis of central nervous system diseases. Meditsinskaya Vizualizatsiya (Medical Visualization, Russian journal). 2012; 4: 113–7 (in Russ.).]

27. Трофимова Т.Н., Тотолян Н.А., Пахомов А.В. Лучевая диагностика рассеянного склероза. СПб.: ЭЛБИ-СПб.; 2010. [Trofimova T.N., Totolyan N.A., Pakhomov A.V. Radiological diagnosis of multiple sclerosis. St. Petersburg: ELBI-SPb.; 2010 (in Russ.).]


Review

For citations:


Panov V.O., Shimanovskiy N.L. THE DIAGNOSTIC EFFICACY AND SAFETY OF MACROCYCLIC GADOLINIUM-BASED MAGNETIC RESONANCE CONTRAST AGENTS. Journal of radiology and nuclear medicine. 2017;98(3):159-166. (In Russ.) https://doi.org/10.20862/0042-4676-2017-98-3-159-166

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