A New Era in Magnetic Resonance Contrast Media

Runge, Val M.; Heverhagen, Johannes T.

doi:10.1097/rli.0000000000001037

Cited by 5 publications

(3 citation statements)

References 38 publications

(48 reference statements)

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“…Third, data on off-label use of gadobutrol or other GBCAs are not discussed. Fourth, comparative safety data of gadobutrol versus the 2 new GBCAs, gadopiclenol and gadoquatrane, 4 were not discussed because of the scarcity of safety findings for these new agents. Finally, published data on safety of gadobutrol's generics could not be found.…”

Section: Results and Assessmentmentioning

confidence: 99%

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Clinical Safety of Gadobutrol: Review of Over 25 Years of Use Exceeding 100 Million Administrations

Endrikat,

Gutberlet,

Hoffmann

et al. 2024

Invest Radiol

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Background The macrocyclic gadolinium-based contrast agent gadobutrol was introduced to the market in February 1998. Over the last 25 years, gadobutrol has been administered more than 100 million times worldwide providing a wealth of data related to safety. Objective The aim of this study was to perform a thorough review and status update on gadobutrol's safety. Materials and Methods Safety data from the clinical phase II–IV program and postmarketing surveillance were descriptively analyzed from February 1998 until December 31, 2022. Literature on special at-risk populations and specific safety aspects was critically summarized. Results Forty-five clinical phase II–IV studies recruited 7856 patients receiving gadobutrol. Drug-related adverse events (AEs) were reported in 3.4% and serious AEs in <0.1% of patients. Nausea (0.7%) and dysgeusia (0.4%) were the most reported AEs. All other drug-related AEs occurred ≤0.3%. After more than 100 million gadobutrol administrations, overall adverse drug reactions (ADRs) from postmarketing surveillance (including clinical trials) were rare with an overall reporting rate of 0.0356%, hypersensitivity reactions (0.0147%), nausea (0.0032%), vomiting (0.0025%), and dyspnea (0.0010%). All other ADRs were <0.001%. No trend for higher rates of AEs was found in patients with reduced renal or liver function. Seven clinical studies reported safety findings in 7292 children ≤18 years, thereof 112 newborns/toddlers younger than 2 years. Overall, 61 ADRs (0.84%) were reported, including 3 serious ones. Adverse events in patients ≥65 years of age (“elderly”) were significantly less frequent than in younger patients. A total of 4 reports diagnostic of or consistent with nephrogenic systemic fibrosis have been received. No causal relationship has been established between clinical signs and symptoms and the presence of small amounts of gadolinium in the body in patients with normal renal function after use of gadobutrol. Conclusions More than 100 million administrations worldwide have shown gadobutrol's well-established benefit-risk profile in any approved indication and populations.

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Section: Results and Assessmentmentioning

confidence: 99%

“…As compared with linear GBCAs, gadobutrol offers higher chelate stability 3,4 . Stability is particularly important for patients who get multiple administrations of GBCAs and for patients with severely impaired renal function who have an increased risk for developing nephrogenic systemic fibrosis (NSF) 5–7 .…”

mentioning

confidence: 99%

Clinical Safety of Gadobutrol: Review of Over 25 Years of Use Exceeding 100 Million Administrations

Endrikat,

Gutberlet,

Hoffmann

et al. 2024

Invest Radiol

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“…Although contrastographic imaging can be obtained with US (CEUS), CT (CECT) and also with MRI, each method offers different sensitivities depending on the contrast agent (CA) used, and it is precisely MRI, thanks to its high sensitivity to CAs, that offers the greatest accuracy in identifying the enhancement of lesions, thanks also to the development of CAs with increasingly high relaxivity that have entered the market in recent months (e.g., Gadopiclenol, Bracco and Guerbet) [1].…”

Section: Introductionmentioning

confidence: 99%

Imaging of the Liver and Pancreas: The Added Value of MRI

Morana,

Beleù,

Geraci

et al. 2024

Diagnostics

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MR is a powerful diagnostic tool in the diagnosis and management of most hepatic and pancreatic diseases. Thanks to its multiple sequences, the use of dedicated contrast media and special techniques, it allows a multiparametric approach able to provide both morphological and functional information for many pathological conditions. The knowledge of correct technique is fundamental in order to obtain a correct diagnosis. In this paper, different MR sequences will be illustrated in the evaluation of liver and pancreatic diseases, especially those sequences which provide information not otherwise obtainable with other imaging techniques. Practical MR protocols with the most common indications of MR in the study of the liver and pancreas are provided.

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Relationship of Dose and Signal Enhancement Properties of Gadoquatrane, a New Tetrameric, Macrocyclic Gadolinium-Based Contrast Agent, Compared With Gadobutrol

Hofmann,

Riecke,

Klein

et al. 2024

Invest Radiol

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Objectives To investigate the signal-enhancement properties of the tetrameric gadolinium-based contrast agent (GBCA) gadoquatrane in relation to the administered dose and compare its properties to those of a standard dose of gadobutrol, as a representative of the currently established macrocyclic GBCAs for magnetic resonance imaging. Materials and Methods In this randomized, single-blind, 4 × 4 crossover study, 43 healthy adults (19–50 years of age) received 3 single IV injections of gadoquatrane (0.01, 0.03, and 0.06 mmol gadolinium/kg body weight) and 1 injection of gadobutrol (0.1 mmol gadolinium/kg body weight) in randomized sequence with 1-week washout periods between administrations. The relative signal enhancement (RSE) was determined in predefined areas of interest in magnetic resonance image sets of the head-neck region. RSE-vs-dose curves (dose-response curves) were established by linear regression, and comparator-equivalent doses were determined by Bayesian inverse regression analysis. Further, 3 blood samples were taken after each injection for pharmacokinetic analyses, and safety data were assessed. Results The RSE increased with gadoquatrane dose. A linear function adequately fitted this relationship. In line with the more than 2-fold higher r1 relaxivity of gadoquatrane per gadolinium ion, gadobutrol-equivalent RSE was achieved with gadoquatrane at less than half the gadolinium dose and less than one eighth of the molecule dose. Administration of gadoquatrane and gadobutrol resulted in very similar dose-normalized gadolinium concentrations in plasma, indicating that the pharmacokinetic profiles are essentially the same. Both contrast agents were well tolerated. Adverse events were rare and not dependent on the dose administered. Conclusions Gadoquatrane has the potential to be an effective GBCA that can be used at substantially lower doses in clinical routine than the currently established macrocyclic GBCAs.

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A New Era in Magnetic Resonance Contrast Media

Cited by 5 publications

References 38 publications

Clinical Safety of Gadobutrol: Review of Over 25 Years of Use Exceeding 100 Million Administrations

Clinical Safety of Gadobutrol: Review of Over 25 Years of Use Exceeding 100 Million Administrations

Imaging of the Liver and Pancreas: The Added Value of MRI

Relationship of Dose and Signal Enhancement Properties of Gadoquatrane, a New Tetrameric, Macrocyclic Gadolinium-Based Contrast Agent, Compared With Gadobutrol

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