Observational Study on the Incidence Nephrogenic Systemic Fibrosis in Patients With Renal Impairment Following Gadoterate Meglumine Administration: t

Posted on: 07/09/2019

In conclusion, the NSsaFe study documents the goodsafety profile of gadoterate meglumine in the population of patients with moderate to severe renal impairment and confirmed the classification of gadoterate meglumine as a low-risk agent for NSF.  Click the link below to read the full article form the Journal of Magnectic Resonance Imaging June 2019.


Nephrogenic systemic fibrosis (NSF) is a rare life‐threatening condition strongly associated with the administration of gadolinium‐based contrast agents in patients with severe or endstage renal impairment.

To prospectively determine the incidence of NSF in patients with renal impairment after administration of gadoterate meglumine.

Study Type

In all, 540 patients with moderate, severe, or endstage renal impairment, scheduled to undergo a routine contrast‐enhanced MRI with gadoterate meglumine. Mean age was 69.7 ± 12.7 years (range: 21–95) with 58.4% of males.

Field Strength/Sequence
1.5T or 3.0T, sequence according to each site practice.

Medical history, indication(s) for current MRI and adverse events were recorded for each patient. Patients were followed up over 2 years after administration with three visits separated by at least 3 months to detect any signs/symptoms suggestive of NSF.

Statistical Tests

Renal impairment was graded as moderate for 69.4% of patients, severe for 16.0% and endstage for 12.1%; 2.6% had undergone a kidney transplant. Estimated glomerular filtration rate ranged from 4 to 59 mL/min/1.73 m2 except one value of 74 mL/min/1.73 m2 in a patient with kidney transplant. Central nervous system exploration was the main MRI indication (34.7%) and mean dose injected was 0.22 ± 0.09 mL/kg. Overall, 446 patients (82.6%) attended at least one follow‐up visit and completed the NSF questionnaire and 329 (60.9%) attended the 2‐year visit. No suspicion of NSF was reported in all 446 patients, including 119 patients with severe or endstage renal impairment. No deaths and no adverse events were reported during the MRI examination and the usual period of follow‐up after gadoterate meglumine administration.

Data Conclusion
No cases of NSF were observed in the 446 patients with moderate to endstage renal impairment followed up over a maximum of 2 years after injection of gadoterate meglumine.

J. Magn. Reson. Imaging 2019.

Authors and researchers:

Richard G. McWilliams, MD, * Jennifer V. Frabizzio, MD, Adelard I. De Backer, MD, Anna Grinberg, PhD, Bart D. Maes, MD, Andreas Gottschalk, MD, and  Bruno Beomonte Zobel, MD.

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