Health services research and policyOpinionNational Institutes of Health Perspective on Reports of Gadolinium Deposition in the Brain
Introduction
Gadolinium-based contrast agents (GBCAs) are currently approved by the FDA for use in conjunction with MRI. GBCAs are indispensable adjuncts to MRI, with numerous studies showing their efficacy in improving the accuracy of MRI studies, and they have a positive cumulative safety record to date. For example, acute adverse reactions have been reported in only approximately 0.079% of all administrations, of which 91% were classified as mild reactions [1]. Despite the positive safety profile immediately after the injection of GBCAs, there has been recent attention to reports of gadolinium deposition in the brains of patients who received multiple doses of GBCAs 2, 3, 4, 5, 6. Although it is not yet known if there is a clinical implication of brain deposition of gadolinium, concerns for patient safety are of paramount importance, and thus internal review of institutional policies on GBCA use are warranted. The purposes of this perspective are to (1) summarize the literature regarding GBCA deposition in the brain and (2) determine any potential impact of that knowledge on how GBCA-enhanced MRI may be performed to minimize patient risk.
Section snippets
Background and Scope
There are nine GBCAs approved by the FDA for clinical use in the United States; GBCA FDA label indications are given in Table 1. Most of these agents are approved for contrast-enhanced imaging of the central nervous system. Only two agents, gadoxetate disodium and gadofosveset trisodium, are approved for indications other than central nervous system pathologies. Gadobutrol is the only agent that is approved by the FDA for use in breast imaging and in patients younger than two years of age.
Recommendations
The long-term impact on public health and safety of deposition of gadolinium in the brain remains unknown. A study group was formed at the National Institutes of Health Clinical Center to investigate the existing literature on gadolinium deposition in the brain parenchyma and to provide recommendations for clinical use of GBCAs within our institution to minimize the potential long-term side effects of GBCA administration. The references summarized in this report conclude that increased signal
Conclusion
The current body of evidence supports the hypothesis that shortening of the T1 relaxation time within the brain parenchyma may result from gadolinium deposition after the injection of linear GBCAs. It is presumed that the deposited gadolinium is a result of dissociation from the chelating molecule. At present, there is no evidence suggesting that gadolinium deposition in the brain alters neurologic function. Although the studies discussed herein assessed a relatively small number of patients,
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The authors have no conflicts of interest related to the material discussed in this article.