Tolerability and diagnostic value of gadoteric acid in the general population and in patients with risk factors: Results in more than 84,000 patients

Maurer, Martin; Heine, Oliver; Wolf, Michael; Durmus, Tahir; Wagner, Moritz; Hamm, Bernd

doi:10.1016/j.ejrad.2011.04.022

Cited by 32 publications

(28 citation statements)

References 21 publications

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“…The study showed that spontaneous adverse reactions occurred in less than 0.01% of patients. In 2007 tolerability and diagnostic value of Gd‐DOTA was reported in >24,000 patients by Herborn et al (60) and again in 2011 in >84,000 patients by Maurer et al (59). These postmarketing studies suggested Gd‐DOTA was a well‐tolerated and safe MRI contrast agent.…”

Section: Adverse Reactions To Gbcasmentioning

confidence: 92%

MRI contrast agents: Basic chemistry and safety

Hao

Goerner

et al. 2012

Magnetic Resonance Imaging

270

191

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Magnetic resonance imaging (MRI) contrast agents are pharmaceuticals used widely in MRI examinations. Gadolinium-based MRI contrast agents (GBCAs) are by far the most commonly used. To date, nine GBCAs have been commercialized for clinical use, primarily indicated in the central nervous system, vasculature, and whole body. GBCAs primarily lower the T(1) in vivo to create higher signal in T(1)-weighted MRI scans where GBCAs are concentrated. GBCAs are unique among pharmaceuticals, being water proton relaxation catalysts whose effectiveness is characterized by a rate constant known as relaxivity. The relaxivity of each GBCAs depends on a variety of factors that are discussed in terms of both the existing agents and future molecular imaging agents under study by current researchers. Current GBCAs can be divided into four different structural types (macrocyclic, linear, ionic, and nonionic) based on the chemistry of the chelating ligands whose primary purpose is to protect the body from dissociation of the relatively toxic Gd(3+) ion from the ligand. This article discusses how the chemical structure influences inherent and in vivo stability toward dissociation, and how it affects important formulation properties. Although GBCAs have a lower rate of serious adverse events than iodinated contrast agents, they still present some risk.

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Section: Adverse Reactions To Gbcasmentioning

confidence: 92%

MRI contrast agents: Basic chemistry and safety

Hao

Goerner

et al. 2012

Magnetic Resonance Imaging

270

191

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“…As the molecular weight of gadobutrol (605 Da) is only slightly higher compared with that of gadoteric acid (559 Da), this property might be of minor importance for EES accumulation. 25,33,44 Unlike gadobenate dimeglumine, gadoteric acid and gadobutrol are generally considered as non-proteinbinding. 25,32,33,48 However, Vogler et al 48 identified an amount of 2.7% protein binding in gadobutrol, although calculations of low protein binding are prone to substantial measurement errors.…”

Section: Discussionmentioning

confidence: 99%

“…25,33,44 Unlike gadobenate dimeglumine, gadoteric acid and gadobutrol are generally considered as non-proteinbinding. 25,32,33,48 However, Vogler et al 48 identified an amount of 2.7% protein binding in gadobutrol, although calculations of low protein binding are prone to substantial measurement errors. 48 If, in fact, gadobutrol possesses some weak protein binding in contrast to gadoteric acid and thus interacts with proteins of the extracellular tumoral matrix, this mechanism could also contribute to the postinitial signal intensity differences.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of Gadoteric Acid and Gadobutrol for Detection as Well as Morphologic and Dynamic Characterization of Lesions on Breast Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Renz

Durmus

Böttcher

et al. 2014

Investigative Radiology

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Objective: In contrast to conventional breast imaging techniques, one major diagnostic benefit of breast magnetic resonance imaging (MRI) is the simultaneous acquisition of morphologic and dynamic enhancement characteristics, which are based on angiogenesis and therefore provide insights into tumor pathophysiology. The aim of this investigation was to intraindividually compare 2 macrocyclic MRI contrast agents, with low risk for nephrogenic systemic fibrosis, in the morphologic and dynamic characterization of histologically verified mass breast lesions, analyzed by blinded human evaluation and a fully automatic computer-assisted diagnosis (CAD) technique. Materials and Methods: Institutional review board approval and patient informed consent were obtained. In this prospective, single-center study, 45 women with 51 histopathologically verified (41 malignant, 10 benign) mass lesions underwent 2 identical examinations at 1.5 T (mean time interval, 2.1 days) with 0.1-mmol kg j1 doses of gadoteric acid and gadobutrol. All magnetic resonance images were visually evaluated by 2 experienced, blinded breast radiologists in consensus and by an automatic CAD system, whereas the morphologic and dynamic characterization as well as the final human classification of lesions were performed based on the categories of the Breast imaging reporting and data system MRI atlas. Lesions were also classified by defining their probability of malignancy (morpho-dynamic index; 0%Y100%) by the CAD system. Imaging results were correlated with histopathology as gold standard. Results: The CAD system coded 49 of 51 lesions with gadoteric acid and gadobutrol (detection rate, 96.1%); initial signal increase was significantly higher for gadobutrol than for gadoteric acid for all and the malignant coded lesions (P G 0.05). Gadoteric acid resulted in more postinitial washout curves and fewer continuous increases of all and the malignant lesions compared with gadobutrol (CAD hot spot regions, P G 0.05). Morphologically, the margins of the malignancies were different between the 2 agents, whereas gadobutrol demonstrated more spiculated and fewer smooth margins (P G 0.05). Lesion classifications by the human observers and by the morpho-dynamic index compared with the histopathologic results did not significantly differ between gadoteric acid and gadobutrol. Conclusions: Macrocyclic contrast media can be reliably used for breast dynamic contrast-enhanced MRI. However, gadoteric acid and gadobutrol differed in some dynamic and morphologic characterization of histologically verified breast lesions in an intraindividual, comparison. Besides the standardization of technical parameters and imaging evaluation of breast MRI, the standardization of the applied contrast medium seems to be important to receive best comparable MRI interpretation.

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“…The absence of CIN after Gd-DOTA administration was initially demonstrated in a small, randomised study conducted in CKD patients [6]. The absence of impact of Gd-DOTA on renal function was further documented in a large Japanese post-marketing study [7], and its good overall safety was confirmed in a surveillance study of 84,621 patients, including 764 patients with renal failure [8]. In a retrospective study conducted by Ergün et al [9] in 91 patients with stage 3 and 4 CKD [mean eGFR by the modified MDRD formula (Modification of Diet in Renal Disease): 33 ml/min/1.73 m 2 ] assessed by magnetic resonance imaging (MRI) with an intravenous dose of 0.2 mmol/kg of Gd-DOTA, gadopentetate dimeglumine, or gadodiamide, 11 patients (12.1 %) developed CIN.…”

Section: Introductionmentioning

confidence: 99%

Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study)

et al. 2012

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ObjectiveTo prospectively compare the renal safety of meglumine gadoterate (Gd-DOTA)-enhanced magnetic resonance imaging (MRI) to a control group (unenhanced MRI) in high-risk patients.MethodsPatients with chronic kidney disease (CKD) scheduled for MRI procedures were screened. The primary endpoint was the percentage of patients with an elevation of serum creatinine levels, measured 72 ± 24 h after the MRI procedure, by at least 25 % or 44.2 μmol/l (0.5 mg/dl) from baseline. A non-inferiority margin of the between-group difference was set at −15 % for statistical analysis of the primary endpoint. Main secondary endpoints were the variation in serum creatinine and eGFR values between baseline and 72 ± 24 h after MRI and the percentage of patients with a decrease in eGFR of at least 25 % from baseline. Patients were screened for signs of nephrogenic systemic fibrosis (NSF) at 3-month follow-up.ResultsAmong the 114 evaluable patients, one (1.4 %) in the Gd-DOTA-MRI group and none in the control group met the criteria of the primary endpoint [Δ = −1.4 %, 95%CI = (−7.9 %; 6.7 %)]. Non-inferiority was therefore demonstrated (P = 0.001). No clinically significant differences were observed between groups for the secondary endpoints. No serious safety events (including NSF) were noted.ConclusionMeglumine gadoterate did not affect renal function and was a safe contrast agent in patients with CKD.Key points• Contrast-induced nephropathy (CIN) is a potential problem following gadolinium administration for MRI.• Meglumine gadoterate (Gd-DOTA) appears safe, even in patients with chronic kidney disease.• Gd-DOTA only caused a temporary creatinine level increase in 1/70 such patients.• No case or sign of NSF was detected at 3-month follow-up.

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Tolerability and diagnostic value of gadoteric acid in the general population and in patients with risk factors: Results in more than 84,000 patients

Cited by 32 publications

References 21 publications

MRI contrast agents: Basic chemistry and safety

MRI contrast agents: Basic chemistry and safety

Comparison of Gadoteric Acid and Gadobutrol for Detection as Well as Morphologic and Dynamic Characterization of Lesions on Breast Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study)

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