Society Recommendations Regarding Gadolinium-Based Contrast Agent Use16,19,51,52
| Society | Summary of Statements and Recommendations | Date |
|---|---|---|
| National Institutes of Health16 | 1. GBCAs should only be used when clinically indicated or when specified in an institutional review board–approved protocol. | March 2016 |
| 2. When GBCAs are required, consider the use of a macrocyclic GBCA (eg, gadobutrol, gadoteridol, or gadoterate meglumine) rather than a linear agent. | ||
| 3. For patients with documented sensitivity (eg, hives) to macrocyclic agents, it is appropriate to use linear agents when clinically indicated. | ||
| 4. MRI protocols should always consider FDA label indications and dosing schemes for administration of GBCAs. | ||
| 5. Encourage intradepartmental and interdepartmental research programs to evaluate T1 shortening in the brain and other organs in patients who have received multiple doses of GBCAs. | ||
| American College of Radiology19 | Would be prudent to consider the clinical benefit of the diagnostic information or treatment result that MRI or MRA may provide against the unknown potential risk of gadolinium deposition in the brain for each individual patient. Particular attention should be paid to pediatric and other patients who may receive many GBCA-enhanced MRI studies over the course of their lifetimes. If the decision for an individual patient is made to use a GBCA for an MRI study, multiple factors need to be considered when selecting a GBCA, including diagnostic efficacy, relaxivity, rate of adverse reactions, dosing/concentration, and propensity to deposit in more sensitive organs such as the brain. As this gadolinium deposition phenomenon remains a relatively undefined clinical phenomenon, and accurate and complete data may be useful as investigations proceed, the identity and dose of GBCA used should be recorded after each intravenous administration. | May 2016 |
| International Society for Magnetic Resonance in Medicine52 | 1. The ISMRM urges caution in the use of any medical compound, including GBCAs. Per standard practice, use of GBCAs should be avoided when not necessary. The evidence on gadolinium deposition emphasizes but does not alter this practice, and GBCAs should not be withheld from patients with a clinical indication for gadolinium-enhanced MRI. The physician responsible for the administration of a contrast agent should understand the benefits and risks of the agent. | July 2017 |
| 2. The clinical indication for which a GBCA is administered, the specific contrast agent used, its dosage, and other pertinent information should be documented in the patient's medical record. | ||
| 3. Some commercially available macrocyclic agents might deposit less gadolinium than some linear agents; however, evidence shows that gadolinium deposition in the brain can also occur after the administration of macrocyclic agents. Evidence suggests differences in gadolinium deposition rates among macrocyclic agents and among linear agents, although some data are discordant. Relaxivity differences between contrast agents and between the potentially deposited chemical species can complicate the interpretation of differences in signal intensity. No evidence shows any harmful effects from the deposition of gadolinium, and therefore whether use of macrocyclic agents should be favored over linear agents is unclear. When choosing a contrast agent, many factors should be considered, including pharmacokinetics, relaxivity, efficacy, potential side effects (such as allergic reactions), patient age, probability of the need for repeated examinations, and cost. Institutions should weigh these factors and consider that some agents might have a greater propensity for deposition than others. | ||
| 4. Given the importance of GBCAs for advancing scientific discovery and improving clinical care, the ISMRM Safety Committee supports the views of the National Institutes of Health, in that administration of GBCAs is appropriate in research settings under the guidance of protocols approved by an institutional review board, and that must include patient's informed consent. Because no risks are known to be associated with gadolinium deposition in the brain, the ISMRM is unable to make an overarching recommendation regarding disclosure of gadolinium deposition to research participants. Therefore, each institution must decide whether inclusion of information on the deposition of gadolinium in the brain is necessary and should be included as part of the consent form; if so, the institution must decide on the description to use. The circumstances under which the GBCA is administered, the unknown risks of gadolinium deposition, and the need to explain the deposition to participants in appropriate language should be taken into account. In the event that new data are available describing adverse biological or clinical effects associated with gadolinium deposition subsequent to this Personal View, it might be appropriate to include that information as part of the consent process. | ||
| 5. Investigators reporting studies on gadolinium deposition in the brain should exercise meticulous disclosure of financial, consulting, and advising relationships with industries as potential conflicts of interest. Although proper disclosure of conflicts of interest must be done for all academic publications, transparency is particularly relevant for studies of gadolinium deposition. | ||
| 6. Because of the potential confounding of disease-related signal intensity changes with gadolinium deposition, future studies should explicitly describe all relevant clinical history of participants, including treatment of the patients in the study. | ||
| Consortium of Multiple Sclerosis Centers51 | GBCAs do accumulate in the brain and to a much lesser degree with macrocyclic agents. While no known CNS toxicity has been identified with the use of GBCAs, these agents should be used judiciously, recognizing that gadolinium continues to play an invaluable role in specific circumstances related to the diagnosis and follow-up of individuals with MS. | February 2018 |
| MS GBCA use is essential for | ||
| • following a patient with highly active disease | ||
| • when there is rapidly declining and unexplained and unexpected clinical worsening occurs | ||
| • when there is concern regarding an alternative diagnosis other than MS | ||
| MS GBCA use is optional for | ||
| • the follow-up monitoring of patients with MS to detect subclinical disease activity that could lead to a change in therapy; the use of GBCA may be helpful within the first 2 years of treatment onset but is not required because new T2 MS lesions can be identified on well-performed MRI using a standardized protocol unless there is a large T2 lesion burden. |
CNS, central nervous system; FDA, US Food and Drug Administration; GBCA, gadolinium-based contrast agent; ISMRM, International Society for Magnetic Resonance in Medicine; MRA, magnetic resonance angiography; MRI, magnetic resonance imaging; MS, multiple sclerosis.