Safety of gadoteridol injection: U.S. clinical trial experience

Olukotun, Adeoye Y.; Parker, John R.; Meeks, Marion J.; Lucas, Maria; Fowler, Dennis R.; Lucas, Thomas W.

doi:10.1002/jmri.1880050106

Cited by 29 publications

(16 citation statements)

References 24 publications

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“…In a recently published overview of the clinical trial experience with gadoteridol in the United States, Olukotun V. M. Runge and J. R. Parker: Worldwide safety of gadoteridol injection S 244 a Exposures resulting in more than one adverse event in a particular body system were counted only once et al reported an overall adverse event rate of 6.9 % irrespective of relationship to drug administration [5]. In this series of 1709 subjects the most commonly noted adverse events were nausea (1.4 %) and taste perversion (1.3 %), findings similar to those made in the present investigation.…”

Section: Discussionmentioning

confidence: 99%

Worldwide clinical safety assessment of gadoteridol injection: an update

Runge

Parker

1997

Eur Radiol

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Gadoteridol injection is a low molecular weight chelate complex of gadolinium (III) which is useful as a contrast agent for magnetic resonance imaging. A total of 2481 adult and pediatric subjects were studied with gadoteridol at doses from 0.025 to 0.3 mmol/kg in phase I-IIIb clinical trials in Europe and the United States. The study population had a mean age of 49 years, and included 119 patients under 18 years of age and 747 patients over 60 years of age. After 2656 administered injections of gadoteridol a total of 233 adverse events were recorded in 176 exposures, an incidence rate of 6.6 % irrespective of relationship to drug administration. The most frequently reported adverse events were nausea (1.5 %), taste perversion (0.9 %), and headache (0.6 %). All other adverse events occurred with an incidence of 0.5 % or less. This report confirms the excellent safety profile of gadoteridol in healthy subjects and patients with a variety of known or suspected pathologies.

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Section: Discussionmentioning

confidence: 99%

Worldwide clinical safety assessment of gadoteridol injection: an update

Runge

Parker

1997

Eur Radiol

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“…Non-ionic complexes with low osmolality ( Table 2) were developed to improve tolerance and allow the use of higher doses [18,25]. Because of the low amounts of compounds injected for MR imaging, the ionic charge of the Gd complexes is not a crucial factor, as the increased plasma osmolality following administration of Gd chelates is very low, unlike what is observed with iodinated contrast media.…”

Section: Osmolalitymentioning

confidence: 97%

“…The safety of MR contrast agents has been shown to be comparable in several studies [2,25,26,27,28,29]. The frequency of single adverse events is approximately 1% or less of all patients [2].…”

Section: Tolerance and Adverse Eventsmentioning

confidence: 98%

“…The LD 50 is defined as the dose of a drug that, when administered to test animals, results in the acute death of half of the test population. The LD 50 value is the highest for gadodiamide (34 mmol/kg), and lowest for gadopentetate (7 mmol/kg; Table 2) [1,2,25], representing respective excesses of approximately 300 and 60 times the typical diagnostic dose of 0.1 mmol/kg, and has minor practical impact.…”

Section: Toxicitymentioning

confidence: 99%

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Currently used non-specific extracellular MR contrast media

2003

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Magnetic resonance contrast agents have demonstrated their clinical usefulness in a variety of organs for improved detection of various neoplastic, inflammatory and functional abnormalities. Gadolinium chelates are the most widely used. They are extracellular, non-specific contrast agents. Their use in many clinical indications is justified because, in conjunction with improved imaging techniques, these safe and image-enhancing contrast agents add morphologic and functional information compared with unenhanced MR images. This article describes the commercially available compounds, and summarizes their approval status on the international market regarding indications and doses. Their mechanisms of action, biodistributions, toxicities and tolerance profiles in normal and high-risk patient populations are described. Additionally, this article reviews the specific recommendations by the manufacturers for patients at risk. Finally, their main clinical applications are reviewed.

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“…However, the nonionic, low viscosity nature of gadoteridol allows it to be given relatively safely and rapidly at three times the concentration of gadopentetate. 43 Furthermore, gadoteridol's macrocyclic structure reduces the rate of dissociation and increases its stability in the intravascular space. 44 These physicochemical properties of gadoteridol make it an ideal agent to be used to evaluate skeletal muscle circulation and detect vascular compromise.…”

Section: Discussionmentioning

confidence: 99%

Magnetic resonance imaging detection of vascular occlusion of a pedicled muscle flap

et al. 1996

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Contrast-enhanced magnetic resonance imaging (MRI) can be a highly sensitive monitor of tissue blood perfusion. This technique has been used to assess blood flow through liver, kidney, and certain tumors, but has not been widely applied to the study of skeletal muscle circulation. In our study, we used a novel scanning software to obtain contrast-enhanced T2*-weighted gradient echo MRI images of pedicled quadriceps muscle flaps in rabbits in order to study images of arterial, venous, and arterio-venous occlusion. We administered an intravenous bolus of gadoteridol contrast agent at the initiation of scanning, which produces a decrease in T2*-signal and improves the sensitivity of measuring blood perfusion. Within 30 seconds of MRI scanning, control flaps with intact pedicles exhibited a rapid decrease in T2*-signal intensity, indicating adequate perfusion of blood through muscle tissue; however, occluded pedicled flaps showed no significant change in signal intensity, indicating lack of blood perfusion. Differences in signal intensities as measured by MRI between occluded and control flaps were statistically significant (P < 0.05). Selective vascular occlusion of either artery alone, or both artery and vein were detected within 15 minutes, whereas selective venous occlusion could be detected after 2 hours. We conclude that MRI has the ability to assess skeletal muscle perfusion, and is capable of noninvasively evaluating a cross-section of tissue in both superficial and buried flaps. MRI, therefore, may have the potential for evaluating perfusion in muscle flaps (including buried flaps), and other disorders of muscle circulation such as compartment syndrome.

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Safety of gadoteridol injection: U.S. clinical trial experience

Cited by 29 publications

References 24 publications

Worldwide clinical safety assessment of gadoteridol injection: an update

Worldwide clinical safety assessment of gadoteridol injection: an update

Currently used non-specific extracellular MR contrast media

Magnetic resonance imaging detection of vascular occlusion of a pedicled muscle flap

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