On the potential causal relationship between gadolinium‐containing MRI agents and nephrogenic systemic fibrosis

Abstract

THERE IS GROWING INTERNATIONAL CONCERN related to the possibility that gadolinium-containing MRI agents are or may be associated with nephrogenic systemic fibrosis (NSF). Nephrogenic systemic fibrosis is known to be a rare multisystem fibrosis disorder that primarily affects the skin but may affect other organs of patients with renal insufficiencies. The opinions expressed in recent publications vary related to the determination of whether intravenous gadolinium-containing MR agents are definitely, possibly, or conditionally associated with the development of NSF. The literature has a range of opinions, a few of which are described here. A recent article in the American Journal of Roentgenology concludes that the development of NSF is strongly associated with gadodiamide administration in the clinical setting of either acute hepatorenal syndrome or dialysis-dependent chronic renal insufficiency (1). A different opinion, stated in the guest editorial published in this issue, stresses that the exposure to gadolinium-containing agents is not currently a proven prerequisite for the onset of NSF (2). Also, in their recent review of 3D contrast-enhanced MR angiography, Zhang et al (3) suggest that gadolinium-based contrast agents do not pose a risk for nephrotoxicity. However, in a letter to the editor that is currently in press with JMRI (4), this suggestion has been challenged. The authors of the letter to the editor note that gadolinium-based contrast agents might induce NSF, a newly identified, debilitating, and potentially fatal disorder (5) in patients with renal insufficiencies. They urge practitioners to stay updated about this emerging disorder and to follow appropriate recommendations. In an article published in this issue, Lin and Brown (6) state that the causal link between high dose gadolinium-containing agents and NSF has not been proven. That article refers to the U.S. Food and Drug Administration (FDA) recommendation that cautious use of any gadolinium in patients with advanced renal failure be applied. This article also recommends that if contrast-enhanced MR examination is necessary, the dose should be limited and dialysis should be promptly performed (7). In addition, the American College of Radiology has just issued guidelines for the utilization of gadolinium-containing MRI contrast agents in patients with renal disease (8). Clearly, consensus is needed concerning the risks and recommended safety guidelines for contrast-enhanced MRI studies. Through JMRI and the society, ISMRM, and its members whom we serve, we have both the opportunity and the responsibility to communicate new and accurate information. This can involve maintaining a balance between disseminating reports with documented credibility related to any MRI issue—including contrast enhancement—while not prematurely raising anxiety with data that are or may be currently incomplete or evolving. With the goal of achieving this balance, JMRI is pleased to participate in and enable peer review for scientific articles and data that result from the special round table discussion and poster session that have been developed for the annual ISMRM/ESMRMB meeting in Berlin on the topic of the potential causal relationship between gadolinium-containing MRI agents and nephrogenic systemic fibrosis (NSF). The round table discussion is scheduled for Tuesday, May 22, 13:30–15:30 hours, and the poster session is scheduled for Thursday, May 24, 14:50–15:30 hours. We anticipate reviewing and potentially publishing in JMRI a summary of conclusions and recommendations that come from these sessions, together with peer-reviewed, revised, and accepted scientific papers on the subject, which we hope to group together in a special section, or possibly in a special issue of JMRI. I encourage each interested ISMRM member's active participation in dialogue related to this topic, including the round table discussion and poster session in Berlin this month. Letters to the editor are welcome! Together we seek the finest scientific data and the finest clinical investigations that can result in appropriate guidelines or boundary conditions for the safe utilization of gadolinium-containing MRI contrast agents in all patients, especially those with severe renal disease.