Is There Long-term Signal Intensity Increase in the Central Nervous System on T1-weighted Images after MR Imaging with the Hepatospecific Contrast Agent Gadoxetic Acid? A Cross-sectional Study in 91 Patients

Kahn, Johannes; Posch, Helena; Steffen, Ingo G.; Geisel, Dominik; Bauknecht, C.; Liebig, Thomas; Denecke, Timm

doi:10.1148/radiol.2016162535

Cited by 53 publications

(40 citation statements)

References 18 publications

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“…Gadovist (Gadavist) Gd-DO3A-butrol Macrocyclic Radbruch et al, 8 Cao et al 9 Gadobenate dimeglumine MultiHance Gd-BOPTA Linear, ionic Weberling et al, 10 Ramalho et al 11 Gadoxetic acid disodium Primovist (Eovist) Gd-EOB-DTPA Linear, ionic Kahn et al 13 Ichikawa et al 12 …”

Section: Gadobutrolmentioning

confidence: 99%

“…[1][2][3][4][5][6][7][8][9][10][11][12][13] Stability both in in vitro and in vivo, relative to the release of gadolinium (which depends upon both thermodynamic and kinetic stability), has been shown to be markedly superior for the macrocyclic agents when compared with the linear agents. [14][15][16][17] The linear nonionic agents (specifically gadodiamide and gadoversetamide) are also markedly less stable by this measure than the linear ionic ones.…”

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confidence: 99%

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Critical Questions Regarding Gadolinium Deposition in the Brain and Body After Injections of the Gadolinium-Based Contrast Agents, Safety, and Clinical Recommendations in Consideration of the EMA's Pharmacovigilance and Risk Assessment Committee Recommendation for Suspension of the Marketing Authorizations for 4 Linear Agents

2017

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For magnetic resonance, the established class of intravenous contrast media is the gadolinium-based contrast agents. In the 3 decades since initial approval, these have proven in general to be very safe for human administration. However, in 2006, a devastating late adverse reaction to administration of the less stable gadolinium-based contrast agents was identified, nephrogenic systemic fibrosis. The result of actions taken by the European Medicines Agency and the US Food and Drug Administration, stratifying the agents by risk and contraindicating specific agents in severe renal dysfunction, has led to no new cases being identified in North America or Europe. Subsequently, in 2014, long-term deposition in the brain of gadolinium was first shown, after administration of 2 nonionic linear chelates, gadodiamide, and gadopentetate dimeglumine. This has led to an intense focus on the question of in vivo distribution, possible dechelation, and subsequent deposition of gadolinium, together with substantial clarification of the phenomenon as well as stratification of the agents on this basis. This review focuses on 8 critical questions regarding gadolinium deposition in the brain and body, with the answers and discussion therein important for future regulatory decisions and clinical practice. It is now clear that dechelation of gadolinium occurs in vivo with the linear agents and is responsible for this phenomenon, with key experts in the field recommending, except where there is no suitable alternative, a shift in clinical practice from the linear to macrocyclic agents. In addition, on March 10, 2017, the Pharmacovigilance and Risk Assessment Committee of the European Medicines Agency recommended suspension of the marketing authorization for 4 linear gadolinium contrast agents-specifically Omniscan, Optimark, Magnevist, and MultiHance (gadodiamide, gadoversetamide, gadopentetate dimeglumine, and gadobenate dimeglumine)-for intravenous injection. Cited in the report was convincing evidence of gadolinium deposition in the brain months after injection of these linear agents. Primovist/Eovist (gadoxetic acid disodium) will remain available, being used at a lower dose for liver imaging, because it meets an important diagnostic need. In addition, a formulation of Magnevist for intra-articular injection will remain available because of its very low gadolinium concentration.

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Section: Gadobutrolmentioning

confidence: 99%

mentioning

confidence: 99%

Critical Questions Regarding Gadolinium Deposition in the Brain and Body After Injections of the Gadolinium-Based Contrast Agents, Safety, and Clinical Recommendations in Consideration of the EMA's Pharmacovigilance and Risk Assessment Committee Recommendation for Suspension of the Marketing Authorizations for 4 Linear Agents

2017

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“…Recently, trace amounts of gadolinium have been detected in the brain of patients after several injections of the linear gadolinium-containing contrast agents gadodiamide, gadopentetate dimeglumine, gadobenate dimeglumine, and gadoversetamide. For gadoxetate, one report has indicated a correlation between the number of prior gadoxetate administrations and increase signal on nonenhanced T1-weighted images in the dentate nucleus [107], while a second report did not find such a correlation [108]. Currently it is not known whether persistence of gadolinium in the brain following therapeutic administration of contrast agents is associated with adverse health consequences.…”

Section: Liver Imaging With Gadoxetatementioning

confidence: 99%

Noninvasive Preclinical and Clinical Imaging of Liver Transporter Function Relevant to Drug-Induced Liver Injury

Kenna

Waterton

Baudy

et al. 2018

Methods in Pharmacology and Toxicology

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Imaging technologies can evaluate many different biological processes in vitro (in cell culture models) and in vivo (in animals and humans), and many are used routinely in investigation of human liver diseases. Some of these methods can help understand liver toxicity caused by drugs in vivo in animals, and druginduced liver injury (DILI) which arises in susceptible humans. Imaging could aid assessment of the relevance to humans in vivo of toxicity caused by drugs in animals (animal/human translation), plus toxicities observed using in vitro model systems (in vitro/in vivo translation). Technologies and probe substrates for quantitative evaluation of hepatobiliary transporter activities are of particular importance. This is due to the key role played by sinusoidal transporter mediated hepatic uptake in DILI caused by many drugs, plus the strong evidence that inhibition of the hepatic bile salt export pump (BSEP) can initiate DILI. Imaging methods for investigation of these processes are reviewed in this chapter, together with their scientific rationale, and methods of quantitative data analysis. In addition to providing biomarkers for investigation of DILI, such approaches could aid the evaluation of clinically relevant drug-drug interactions mediated via hepatobiliary transporter perturbation.

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“…Historically, some cases of nephrogenic system fibrosis in kidney patients have been reported after the use of gadolinium, and it is contraindicated for renal studies in several institutions. Moreover, new evidence suggests that gadolinium is deposited in the brain …”

Section: Introductionmentioning

confidence: 99%

“…Moreover, new evidence suggests that gadolinium is deposited in the brain. 9 ASL is a noninvasive alternative to study renal physiology where the blood entering the kidneys is used as a contrast agent. Recently, it has been reported that the perfusion in the cortex measured with ASL is affected by kidney diseases.…”

Section: Introductionmentioning

confidence: 99%

Dissolved hyperpolarized xenon‐129 MRI in human kidneys

Chacon‐Caldera

Maunder

Rao

et al. 2019

Magnetic Resonance in Med

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Purpose To assess the feasibility of using dissolved hyperpolarized xenon‐129 (129Xe) MRI to study renal physiology in humans at 3 T. Methods Using a flexible transceiver RF coil, dynamic and spatially resolved 129Xe spectroscopy was performed in the abdomen after inhalation of hyperpolarized 129Xe gas with 3 healthy male volunteers. A transmit‐only receive‐only RF coil array was purpose‐built to focus RF excitation and enhance sensitivity for dynamic imaging of 129Xe uptake in the kidneys using spoiled gradient echo and balanced steady‐state sequences. Results Using spatially resolved spectroscopy, different magnitudes of signal from 129Xe dissolved in red blood cells and tissue/plasma could be identified in the kidneys and the aorta. The spectra from both kidneys showed peaks with similar amplitudes and chemical shift values. Imaging with the purpose‐built coil array was shown to provide more than a 3‐fold higher SNR in the kidneys when compared with surrounding tissues, while further physiological information from the dissolved 129Xe in the lungs and in transit to the kidneys was provided with the transceiver coil. The signal of dissolved hyperpolarized 129Xe could be imaged with both tested sequences for about 40 seconds after inhalation. Conclusion The uptake of 129Xe dissolved in the human kidneys was measured with spectroscopic and imaging experiments, demonstrating the potential of hyperpolarized 129Xe MR as a novel, noninvasive technique to image human kidney tissue perfusion.

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Is There Long-term Signal Intensity Increase in the Central Nervous System on T1-weighted Images after MR Imaging with the Hepatospecific Contrast Agent Gadoxetic Acid? A Cross-sectional Study in 91 Patients

Cited by 53 publications

References 18 publications

Noninvasive Preclinical and Clinical Imaging of Liver Transporter Function Relevant to Drug-Induced Liver Injury

Dissolved hyperpolarized xenon‐129 MRI in human kidneys

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