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Congress: ECR24
Poster Number: C-16702
Type: EPOS Radiologist (scientific)
Authorblock: S. Gruendemann, F. Kreis, P. Severin, G. Jost, J. Lohrke, H. Pietsch; Berlin/DE
Disclosures:
Stephan Gruendemann: Employee: Bayer AG
Felix Kreis: Employee: Bayer AG
Philipp Severin: Employee: Bayer AG
Gregor Jost: Employee: Bayer AG
Jessica Lohrke: Employee: Bayer AG
Hubertus Pietsch: Employee: Bayer AG
Keywords: Contrast agents, MR, Contrast agent-intravenous, Physics, Safety, Toxicity
Purpose The efficacy and clinical utility of gadolinium-based contrast agents (GBCAs) in contrast-enhanced magnetic resonance imaging (CE-MRI) is well established in clinical routine [1]. In the last decades more that >700 million procedures with GBCAs have been performed. It has been shown that these compounds are generally well-tolerated and exhibit an excellent safety profile [2-4].The discovery of nephrogenic systemic fibrosis (NSF) in 2006 [5] and the association between repeated use of GBCAs and MRI signal hyperintensities in certain brain regions in...
Read more Methods and materials Contrast Agents: The study investigated two high relaxivity macrocyclic GBCAs: gadoquatrane (Phase 3 formulation, Bayer AG, Berlin), gadopiclenol (Vueway, Bracco Diagnostics Inc., USA). For relaxivity measurements gadobutrol (Gadovist, Bayer Vital GmbH, Leverkusen) was measured additionally as a reference.Relaxivity measurements: Human plasma was sourced from three male and three female donors. Solutions of gadoquatrane, gadopiclenol and gadobutrol in aliquots of the individual donor plasmas at three different target concentrations of 250, 500 and 1000 μmol/L were produced. Additionally, one blank plasma...
Read more Results The NMRD profiles in plasma show that at clinically relevant field strengths both agents show similar r1-relaxivities per Gd atom. The r1 relaxivities (L/mmol/s) measured at these field strengths were: gadoquatrane 11.4±0.4 @1.41T and 10.0±0.6 @3.0T; gadopiclenol 12.4±0.6 @1.41T and 11.5±0.8 @3.0T. The r1-relaxivities of the reference contrast agent gadobutrol were measured as 5.2±0.1 @1.41T and 4.6±0.3 @3.0T which is in accordance with literature values [19]. The reported uncertainty represents the standard deviation calculated from the relaxivities, each individually measured...
Read more Conclusion In this study some physico-chemical properties of the next generation, high relaxivity MRI contrast agents gadopiclenol (commercially available in US, approved in EU) and gadoquatrane (currently in clinical phase 3) were compared. Both exhibit r1 relaxivities which are >2 fold higher compared to gadobutrol with a notable distribution due to human plasma variability. While there was no detectable release of gadolinium in blood plasma for gadoquatrane, gadopiclenol showed an observable gadolinium release over a period of 15 days. This high...
Read more References Lohrke, J., et al., 25 Years of Contrast-Enhanced MRI: Developments, Current Challenges and Future Perspectives. Adv Ther, 2016. 33(1): p. 1-28. Endrikat, J., et al., Safety of Gadobutrol: Results From 42 Clinical Phase II to IV Studies and Postmarketing Surveillance After 29 Million Applications. Invest Radiol, 2016. 51(9): p. 537-43. de Kerviler, E., et al., Adverse Reactions to Gadoterate Meglumine Review of Over 25 Years of Clinical Use and More Than 50 Million Doses. Investigative Radiology, 2016. 51(9): p. 544-551. Morgan, D.E., et...
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