Skip to main content
Top
Published in: Abdominal Radiology 4/2015

01-04-2015

Inter- and intra-individual comparative study of two gadolinium-based agents: A pilot study

Authors: Kyung Sook Shin, Mamdoh AlObaidy, Miguel Ramalho, Yong Hwan Jeon, Lauren M. Burke, Ersan Altun, Clifton G. Stallings, Richard C. Semelka

Published in: Abdominal Radiology | Issue 4/2015

Login to get access

Abstract

Purpose

The aim of the study was to evaluate the acute adverse events rate and enhancement properties of gadoterate meglumine (Dotarem®) and gadobenate dimeglumine (MultiHance®) in a small-scale controlled double-blinded study, using inter- and intra-individual comparisons.

Materials and Methods

Forty-one randomly selected patients were scanned with Dotarem®. The rate of adverse reactions, qualitative and quantitative image evaluation was performed vs. a control group of 46 patients who underwent MultiHance® over the same 1-month time period (population 1), and 27 patients who underwent both Dotarem® and MultiHance®-enhanced body MRI studies within an 18-month period (population 2). Data were subjected to statistical analysis.

Results

Only 1 mild acute adverse event (vomiting) was observed in population 1 (with Dotarem®). Blinded assessment of image quality was good for both agents in all patients. Population 1 showed significantly higher liver percentage enhancement with MultiHance® (p < 0.0001). There was a trend to higher pancreas-to-liver enhancement with Dotarem®, significant in population 2 (p = 0.0333).

Conclusion

This small-scale multi-blinded study characterizes a strategy to objectively assess intravenous contrast agents, which may be an ideal method to evaluate whether a new contrast agent should be introduced for clinical use at any institution, and to re-evaluate the agent in standard use. Whenever available, intra-individual assessment may be ideal.
Literature
5.
go back to reference Kuwatsuru R, Kadoya M, Ohtomo K, et al. (2001) Comparison of gadobenate dimeglumine with gadopentetate dimeglumine for magnetic resonance imaging of liver tumors. Invest Radiol 36:632–641CrossRefPubMed Kuwatsuru R, Kadoya M, Ohtomo K, et al. (2001) Comparison of gadobenate dimeglumine with gadopentetate dimeglumine for magnetic resonance imaging of liver tumors. Invest Radiol 36:632–641CrossRefPubMed
6.
go back to reference Tombach B, Bohndorf K, Brodtrager W, et al. (2008) Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: results of a multicenter, single-blind, interindividual, randomized clinical phase III trial. Eur Radiol 18:2610–2619. doi:10.1007/s00330-008-1054-2 CrossRefPubMed Tombach B, Bohndorf K, Brodtrager W, et al. (2008) Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: results of a multicenter, single-blind, interindividual, randomized clinical phase III trial. Eur Radiol 18:2610–2619. doi:10.​1007/​s00330-008-1054-2 CrossRefPubMed
7.
go back to reference Kuhn J-P, Hegenscheid K, Siegmund W, et al. (2009) Normal dynamic MRI enhancement patterns of the upper abdominal organs: gadoxetic acid compared with gadobutrol. AJR Am J Roentgenol 193:1318–1323. doi:10.2214/AJR.09.2412 CrossRefPubMed Kuhn J-P, Hegenscheid K, Siegmund W, et al. (2009) Normal dynamic MRI enhancement patterns of the upper abdominal organs: gadoxetic acid compared with gadobutrol. AJR Am J Roentgenol 193:1318–1323. doi:10.​2214/​AJR.​09.​2412 CrossRefPubMed
8.
go back to reference Hammerstingl R, Adam G, Ayuso J-R, et al. (2009) Comparison of 1.0 M gadobutrol and 0.5 M gadopentetate dimeglumine-enhanced magnetic resonance imaging in five hundred seventy-two patients with known or suspected liver lesions: results of a multicenter, double-blind, interindividual, randomized clinical phase-III trial. Invest Radiol 44:168–176. doi:10.1097/RLI.0b013e318198a0ae CrossRefPubMed Hammerstingl R, Adam G, Ayuso J-R, et al. (2009) Comparison of 1.0 M gadobutrol and 0.5 M gadopentetate dimeglumine-enhanced magnetic resonance imaging in five hundred seventy-two patients with known or suspected liver lesions: results of a multicenter, double-blind, interindividual, randomized clinical phase-III trial. Invest Radiol 44:168–176. doi:10.​1097/​RLI.​0b013e318198a0ae​ CrossRefPubMed
10.
go back to reference Weber JCP (1984) Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drug, vol 6. In: Rainsford KD, Velo GP (ed). Raven Press, New York, pp 1–7 Weber JCP (1984) Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drug, vol 6. In: Rainsford KD, Velo GP (ed). Raven Press, New York, pp 1–7
13.
go back to reference Semelka RC, Hernandes M de A, Stallings CG, Castillo M (2013) Objective evaluation of acute adverse events and image quality of gadolinium-based contrast agents (gadobutrol and gadobenate dimeglumine) by blinded evaluation. Pilot study. Magn Reson Imaging 31:96–101. doi:10.1016/j.mri.2012.06.025 CrossRefPubMed Semelka RC, Hernandes M de A, Stallings CG, Castillo M (2013) Objective evaluation of acute adverse events and image quality of gadolinium-based contrast agents (gadobutrol and gadobenate dimeglumine) by blinded evaluation. Pilot study. Magn Reson Imaging 31:96–101. doi:10.​1016/​j.​mri.​2012.​06.​025 CrossRefPubMed
15.
go back to reference Runge VM, Kenney CM (2000) Phase II double-blind, dose-ranging clinical evaluation of gadobenate dimeglumine in focal liver lesions: with analysis of liver and kidney signal change on early and delayed imaging. J Magn Reson Imaging 11:655–664. doi:10.1002/1522-2586(200006)11:6<655::AID-JMRI12>3.0.CO;2-HCrossRefPubMed Runge VM, Kenney CM (2000) Phase II double-blind, dose-ranging clinical evaluation of gadobenate dimeglumine in focal liver lesions: with analysis of liver and kidney signal change on early and delayed imaging. J Magn Reson Imaging 11:655–664. doi:10.1002/1522-2586(200006)11:6<655::AID-JMRI12>3.0.CO;2-HCrossRefPubMed
16.
17.
19.
go back to reference Landis JR, Koch GG (1977) An application of hierarchical kappa-type statistics in the assessment of majority agreement among multiple observers. Biometrics 33(2):363–374CrossRefPubMed Landis JR, Koch GG (1977) An application of hierarchical kappa-type statistics in the assessment of majority agreement among multiple observers. Biometrics 33(2):363–374CrossRefPubMed
20.
go back to reference Core Team R (2014) R: A language and environment for statistical computing, 3rd edn. Vienna: Austria Core Team R (2014) R: A language and environment for statistical computing, 3rd edn. Vienna: Austria
23.
go back to reference Herborn CU, Honold E, Wolf M, et al. (2007) Clinical safety and diagnostic value of the gadolinium chelate gadoterate meglumine (Gd-DOTA). Invest Radiol 42:58–62CrossRefPubMed Herborn CU, Honold E, Wolf M, et al. (2007) Clinical safety and diagnostic value of the gadolinium chelate gadoterate meglumine (Gd-DOTA). Invest Radiol 42:58–62CrossRefPubMed
25.
go back to reference Herborn CU, Jager-Booth I, Lodemann KP, Spinazzi A, Goyen M (2009) Multicenter analysis of tolerance and clinical safety of the extracellular MR contrast agent gadobenate dimeglumine (MultiHance). Rofo 181:652–657. doi:10.1055/s-0028-1109202 CrossRefPubMed Herborn CU, Jager-Booth I, Lodemann KP, Spinazzi A, Goyen M (2009) Multicenter analysis of tolerance and clinical safety of the extracellular MR contrast agent gadobenate dimeglumine (MultiHance). Rofo 181:652–657. doi:10.​1055/​s-0028-1109202 CrossRefPubMed
26.
go back to reference Oudkerk M, Sijens PE, Van Beek EJ, Kuijpers TJ (1995) Safety and efficacy of dotarem (Gd-DOTA) versus magnevist (Gd-DTPA) in magnetic resonance imaging of the central nervous system. Invest Radiol 30:75–78CrossRefPubMed Oudkerk M, Sijens PE, Van Beek EJ, Kuijpers TJ (1995) Safety and efficacy of dotarem (Gd-DOTA) versus magnevist (Gd-DTPA) in magnetic resonance imaging of the central nervous system. Invest Radiol 30:75–78CrossRefPubMed
27.
go back to reference Rohrer M, Bauer H, Mintorovitch J, Requardt M, Weinmann H-J (2005) Comparison of magnetic properties of MRI contrast media solutions at different magnetic field strengths. Invest Radiol 40:715–724CrossRefPubMed Rohrer M, Bauer H, Mintorovitch J, Requardt M, Weinmann H-J (2005) Comparison of magnetic properties of MRI contrast media solutions at different magnetic field strengths. Invest Radiol 40:715–724CrossRefPubMed
28.
go back to reference Kim MJ, Kim SH, Kim HJ, et al. (2013) Enhancement of liver and pancreas on late hepatic arterial phase imaging: quantitative comparison among multiple gadolinium-based contrast agents at 1.5 tesla MRI. J Magn Reson Imaging 38:102–108. doi:10.1002/jmri.23934 CrossRefPubMed Kim MJ, Kim SH, Kim HJ, et al. (2013) Enhancement of liver and pancreas on late hepatic arterial phase imaging: quantitative comparison among multiple gadolinium-based contrast agents at 1.5 tesla MRI. J Magn Reson Imaging 38:102–108. doi:10.​1002/​jmri.​23934 CrossRefPubMed
29.
go back to reference Kim HJ, Kim BS, Kim MJ, et al. (2012) Enhancement of the liver and pancreas in the hepatic arterial dominant phase: comparison of hepatocyte-specific MRI contrast agents, gadoxetic acid and gadobenate dimeglumine, on 3 and 1.5 tesla MRI in the same patient. J Magn Reson Imaging 37:903–908. doi:10.1002/jmri.23874 CrossRefPubMed Kim HJ, Kim BS, Kim MJ, et al. (2012) Enhancement of the liver and pancreas in the hepatic arterial dominant phase: comparison of hepatocyte-specific MRI contrast agents, gadoxetic acid and gadobenate dimeglumine, on 3 and 1.5 tesla MRI in the same patient. J Magn Reson Imaging 37:903–908. doi:10.​1002/​jmri.​23874 CrossRefPubMed
30.
go back to reference Murphy KP, Szopinski KT, Cohan RH, Mermillod B, Ellis JH (1999) 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. Acad Radiol 6:656–664. doi:10.1016/S1076-6332(99)80114-7 CrossRefPubMed Murphy KP, Szopinski KT, Cohan RH, Mermillod B, Ellis JH (1999) 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. Acad Radiol 6:656–664. doi:10.​1016/​S1076-6332(99)80114-7 CrossRefPubMed
Metadata
Title
Inter- and intra-individual comparative study of two gadolinium-based agents: A pilot study
Authors
Kyung Sook Shin
Mamdoh AlObaidy
Miguel Ramalho
Yong Hwan Jeon
Lauren M. Burke
Ersan Altun
Clifton G. Stallings
Richard C. Semelka
Publication date
01-04-2015
Publisher
Springer US
Published in
Abdominal Radiology / Issue 4/2015
Print ISSN: 2366-004X
Electronic ISSN: 2366-0058
DOI
https://doi.org/10.1007/s00261-014-0248-0

Other articles of this Issue 4/2015

Abdominal Radiology 4/2015 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.